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Head and Neck CancersNCT05648682

Comparison of the Effectiveness of Three Different Gargates in Radiotherapy-Associated Oral Mucositis

A study testing Salin, Sodium bicarbonate and Thyme honey in people with Head and Neck Cancers and Oral Mucositis, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was conducted to compare the effectiveness of thyme honey, saline and sodium bicarbonate solution in the management of oral mucositis in patients with head and neck cancer receiving radiotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancers, Oral Mucositis
What is being tested?
Salin, Sodium bicarbonate and Thyme honey
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2020to 1 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary diagnosis is head and neck cancer
  • To be receiving radiotherapy at a dose of 50-60 Gy in the oral cavity
  • Not be metastatic
  • OM grade 1 (according to NCI-CTCAE v4.03)
  • Be 18 years or older
  • Volunteer to participate in the study
  • Speak Turkish

Who cannot join

  • Have an autoimmune disease
  • Have dental disease
  • Using dentures
  • Being allergic to thyme honey
  • Refusing to participate in the research
  • To have received radiotherapy treatment in the 6-month period before the start of the study
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  • Criteria for terminating the study
  • The patient's desire to leave the study
  • Continuing the treatment in another city
  • Interruption or termination of radiotherapy treatment
  • Patient's death

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Zeynep YILMAZ

    Bilecik

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effectiveness of Three Different Gargates in Radiotherapy-Associated Oral Mucositis Management in Head and Neck Cancer Patients: A Randomized Controlled Study

This study was conducted to compare the effectiveness of thyme honey, saline and sodium bicarbonate solution in the management of oral mucositis in patients with head and neck cancer receiving radiotherapy.

Read the detailed description

The research was conducted as a randomized controlled clinical trial between January 2020 and January 2022. The sample of the research; Patients who applied to Hospital Radiotherapy Unit, received 50-60 Gy radiotherapy in the oral cavity, had a primary diagnosis of head and neck cancer, had no metastasis, had no complaints about mucositis, were older than 18 years old, spoke Turkish, and agreed to participate, in the study. With the closed-envelope randomization method, 48 patients were included in the sample, 12 patients for each of the saline, sodium bicarbonate, thyme honey, and control groups. The routine protocol of the clinic was applied to the control group. Patients in the intervention group (thyme honey, saline and sodium bicarbonate group) were treated 3 times a day for 6 weeks, in addition to the routine protocol of the clinic; they were asked to gargle with 20 ml of the solution in the group they were randomized to, 15 minutes before, 15 minutes and 6 hours after radiotherapy. Intraoral evaluations were made every week by the responsible physician of the radiotherapy unit, who did not know which group the patients were in (single blind). Study data; Obtained using the Sociodemographic and Disease Data Collection Form, the National Cancer Institute Common Toxicity Criteria v4.03, the Oral Evaluation Guide, and the Washington University Quality of Life Questionnaire. In the study, Chi-square analysis was used for the relationship between two categorical variables, One-way Anova for differences in measurements, Levene test for homogeneity of variance, and Bonferroni analysis to find out from which group or groups the difference originated. Support was received from the Health Sciences University Scientific Research Project Office for the study (2020/029)

Being tested
Salin, Sodium bicarbonate, Thyme honey, Control
Keywords
nurse, radiotherapy, salin, sodium bicarbonate, thyme honey, Head and Neck Cancers, Oral Mucositis
Medical subject headings
Head and Neck Neoplasms, Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SalinOther

    Patients were told that they should gargle using approximately 2 tablespoons of the solution given for each use. SF solution was obtained from the medical company as 500 ml separately for each patient.

  • Sodium bicarbonateOther

    Patients were told that they should gargle using approximately two tablespoons of the solution given for each use. The 500 ml distilled water bottle to be used for the SB solution was obtained from the medical company, separately for each patient.

  • Thyme honeyOther

    Patients were told that they should gargle using approximately 2 tablespoons of the solution given for each use.

  • ControlOther

    The patients continued to use the antifungal solution containing the active ingredient nystatin, which was prescribed routinely in the clinical procedure, 3 times a day.

Study groups in NCT05648682
Study groupRoleWhat they receive
SalineExperimentalThe patients in the group gargling with saline were given in a 500 ml bottle at each visit for one week of use. Patients were told that they should gargle using approximately two tablespoons of the solution given for each usage.
Receives: Other: Salin
Sodium BicarbonateExperimentalThe sodium bicarbonate solution prepared by the researcher by mixing one teaspoon of baking soda (4.5 grams) into 500 ml of distilled water by the researcher was given to the patients in the group gargling with sodium bicarbonate for a one-week use at each interview. Patients were told that they should gargle using approximately two tablespoons of the solution given for each usage.
Receives: Other: Sodium bicarbonate
Thyme HoneyExperimental20 ml of honey was diluted in 100 ml distilled water bottles by the researcher to the patients in the group gargling with thyme honey. For a week's use, the patient was given five honey solutions in 100 ml bottles at one time at each visit. Patients were told that they should gargle using approximately two tablespoons of the solution given for each use.
Receives: Other: Thyme honey
ControlExperimentalNo solution was given to the patients in the control group by the researcher.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=0 patient has oral mucositis

    Measured: Week 0

  2. Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=6 patients have oral mucositis

    Measured: First week of radiotherapy

  3. Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change= 12 patients have oral mucositis

    Measured: Second week of radiotherapy

  4. Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Third week of radiotherapy

  5. Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Fourth week of radiotherapy

  6. Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Fifth week of radiotherapy

  7. Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Sixth week of radiotherapy

  8. Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=0 patient has oral mucositis

    Measured: Week 0

  9. Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=4 patients have oral mucositis

    Measured: First week of radiotherapy

  10. Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Second week of radiotherapy

  11. Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Third week of radiotherapy

  12. Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Fourth week of radiotherapy

  13. Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Fifth week of radiotherapy

  14. Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=11 patients have oral mucositis

    Measured: Sixth week of radiotherapy

  15. Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=0 patient has oral mucositis

    Measured: Week 0

  16. Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=4 patients have oral mucositis

    Measured: First week of radiotherapy

  17. Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Second week of radiotherapy

  18. Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Third week of radiotherapy

  19. Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Fourth week of radiotherapy

  20. Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Fifth week of radiotherapy

  21. Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=11 patients have oral mucositis

    Measured: Sixth week of radiotherapy

  22. Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=0 patient has oral mucositis

    Measured: Week 0

  23. Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=0 patient has oral mucositis

    Measured: First week of radiotherapy

  24. Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=8 patients have oral mucositis

    Measured: Second week of radiotherapy

  25. Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Third week of radiotherapy

  26. Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Fourth week of radiotherapy

  27. Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Fifth week of radiotherapy

  28. Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have oral mucositis

    Measured: Sixth week of radiotherapy

  29. Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=0 patient has Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Week 0

  30. Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=6 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: First week of radiotherapy

  31. Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Second week of radiotherapy

  32. Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Third week of radiotherapy

  33. Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=4 patients have Grade 1-2 oral mucositis 8 patients have Grade 3 oral mucositis

    Measured: Fourth week of radiotherapy

  34. Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=7 patients have Grade 1-2 oral mucositis 5 patients have Grade 3 oral mucositis

    Measured: Fifth week of radiotherapy

  35. Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Sixth week of radiotherapy

  36. Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=0 patient has Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Week 0

  37. Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=4 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: First week of radiotherapy

  38. Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Second week of radiotherapy

  39. Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Third week of radiotherapy

  40. Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=4 patients have Grade 1-2 oral mucositis 8 patients have Grade 3 oral mucositis

    Measured: Fourth week of radiotherapy

  41. Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=10 patients have Grade 1-2 oral mucositis 2 patients have Grade 3 oral mucositis

    Measured: Fifth week of radiotherapy

  42. Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=11 patients have Grade 1-2 oral mucositis

    1 patient has Grade 3 oral mucositis

    Measured: Sixth week of radiotherapy

  43. Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=0 patient has Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Week 0

  44. Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=4 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: First week of radiotherapy

  45. Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Second week of radiotherapy

  46. Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=11 patients have Grade 1-2 oral mucositis

    1 patient has Grade 3 oral mucositis

    Measured: Third week of radiotherapy

  47. Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=7 patients have Grade 1-2 oral mucositis 5 patients have Grade 3 oral mucositis

    Measured: Fourth week of radiotherapy

  48. Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=7 patients have Grade 1-2 oral mucositis 5 patients have Grade 3 oral mucositis

    Measured: Fifth week of radiotherapy

  49. Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=10 patients have Grade 1-2 oral mucositis 2 patients have Grade 3 oral mucositis

    Measured: Sixth week of radiotherapy

  50. Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=0 patient has Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Week 0

  51. Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=0 patient has Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: First week of radiotherapy

  52. Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=8 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Second week of radiotherapy

  53. Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Third week of radiotherapy

  54. Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=11 patients have Grade 1-2 oral mucositis

    1 patient has Grade 3 oral mucositis

    Measured: Fourth week of radiotherapy

  55. Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=11 patients have Grade 1-2 oral mucositis

    1 patient has Grade 3 oral mucositis

    Measured: Fifth week of radiotherapy

  56. Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis.

    Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Measured: Sixth week of radiotherapy

  57. Control group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=83,57

    Measured: Week 0

  58. Control group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=73,71

    Measured: Second week of radiotherapy

  59. Control group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=65,30

    Measured: Fifth week of radiotherapy

  60. Saline group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=82,99

    Measured: Week 0

  61. Saline group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=69,67

    Measured: Second week of radiotherapy

  62. Saline group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=65,30

    Measured: Fifth week of radiotherapy

  63. Sodium bicarbonate group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=75,31

    Measured: Week 0

  64. Sodium bicarbonate group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=62,17

    Measured: Second week of radiotherapy

  65. Sodium bicarbonate group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=52,56

    Measured: Fifth week of radiotherapy

  66. Thyme honey group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=85,59

    Measured: Week 0

  67. Thyme honey group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=73,71

    Measured: Second week of radiotherapy

  68. Thyme honey group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100".

    Change=70,42

    Measured: Fifth week of radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2022
  2. Study start1 Jan 2020
  3. Primary completion1 Jan 2021
  4. Study completion1 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05648682
Sponsor's protocol ID
SBU_RKC
Status last verified
Dec 2022
First submitted
25 Nov 2022
Last updated
13 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Salin, Sodium bicarbonate and Thyme honey in people with Head and Neck Cancers and Oral Mucositis, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03) (time frame: Week 0). The study lists 68 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05648682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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