Head and Neck Cancer PatientsPhase 4NCT05859711
Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients
A Phase 4 study testing thyme honey mouth rinse and saline mouth rinse in people with Head and Neck Cancer Patients, run by Ain Shams University at 1 site in Egypt.
Trial summary
Xerostomia is the most frequent complication among patients who receive radiotherapy (RT) . The prevalence of xerostomia has been reported to be from 73.5% to 93% (Kakoei S.,2012). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Head and Neck Cancer Patients
- What is being tested?
- thyme honey mouth rinse and saline mouth rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2021to 20 Jun 2021
- Phase
- Phase 4
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to non-palliative head and neck radiotherapy
- Total dose of radiation received (50-70 Gy)
- Patients with complaint of xerostomia
- Age 25-65 years old
- Objective dry mouth score from ( 2-5)
- Subjective dry mouth score from (1-4)
- Undergoing radiotherapy for at least three weeks
- Can independently complete the questionnaire
Who cannot join
- Have confirmed systemic diseases or medications associated with xerostomia
- Have a known allergy to honey
- Patients who had salivary glands removal surgery
- Patients with salivary gland diseases or malignancy
- Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients A Randomized Controlled Clinical Trial With a Biochemical Assessment
Xerostomia is the most frequent complication among patients who receive radiotherapy (RT) . The prevalence of xerostomia has been reported to be from 73.5% to 93% (Kakoei S.,2012). Damage to normal tissues can result by radiotherapy as it is not selective to cancer cells, and so affecting the quality of life of patients. Honey is one of the methods studied by CIM for management of HNC treatment side effects due to its properties. (Brennan et al., 2002; Clarkson et al., 2007; Furness et al., 2011;Hackett et al., 2015).
Thyme honey is a new alternative for management of xerostomia, which is a propolis gel product. Thyme honey is a variety of monofloral honey made from the nectar and pollen of thyme flowers. It has a strong antioxidant, antibacterial, antifungal and immuno modulating health effects. Due to the high sugar concentration in honey, it is believed that its presence in the oral cavity has a sialogogue effect, stimulating the salivary glands to produce saliva.
Read the detailed description
90 post radiation cancer patients were randomly assigned into two equal groups.The intervention group will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. Patients in the control arm followed the same protocol with normal saline rinses. The treatment assessment of subjective dry mouth score, objective dry mouth score, salivary Ph and salivary flow rate will be carried out at baseline, 2 weeks and one month after starting of the treatment protocol (Charalambous et al., 2017).
Nitric oxide levels will be measured at baseline and after one month of treatment (Abadi et al., 2020).
- Conditions
- Head and Neck Cancer Patients
- Being tested
- thyme honey mouth rinse, saline mouth rinse
- Keywords
- xerostomia, thyme honey, nitric oxide
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyme honey mouth rinseDrug
oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017)
saline mouth rinseDrug
saline mouth rinse 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| thyme honey | Experimental | oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017) Receives: Drug: thyme honey mouth rinse |
| Saline | Active comparator | oral rinses with saline 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. Receives: Drug: saline mouth rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective dry mouth score
Q1. Do you feel dryness in your mouth ? Q2. Do you drink liquids to help you swallow dry food? Q3. Do you feel mouth dryness when eating a meal? Q4. Does the saliva seem to be too little in your mouth? Subjects who answered confirmatively to at least one of those questions related to dry mouth will be considered as positive for oral dryness subjective complaints.
Measured: change from baseline at 4 weeks
Secondary outcomes (4)
objective dry mouth score
Objective dry mouth score:
The patients will be examined for their signs of dry mouth including:
(Osailan et al., 2011).
- pooled saliva loss
- stickiness of mouth mirror to buccal mucosa
- stringy or foamy appearance of saliva
- dehydration of the lips
- no response to parotid stimulation Calculation of Objective dry mouth scores will be according to the number of dry mouth signs observed (0-5) and patients with less than 2 score will be excluded
Measured: change from baseline at 4 weeks
salivary PH
identification of PH according to the color of the PH paper
Measured: change from baseline at 4 weeks
nitric oxide levels
assessment of nitric oxide levels in the salivary samples using ELISA
Measured: change from baseline at 4 weeks
Salivary flow rate
assessing unstimulated salivary flow rate in 5 minutes
Measured: change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start20 Feb 2021
- Primary completion20 Jun 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Magdi, Ain Shams University
- Investigators
- Susan Seif, professor, Study director, faculty of dentistry- Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859711
- Sponsor's protocol ID
- FDASU-REC 111
- Status last verified
- Sep 2025
- First submitted
- 5 Apr 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients A Randomized Controlled Clinical Trial With a Biochemical Assessment
- ClinicalTrials.gov ID
- NCT05859711
- Acronym / sponsor ID
- FDASU-REC 111
- Conditions
- Head and Neck Cancer Patients
- Keywords
- xerostomia, thyme honey, nitric oxide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Xerostomia is the most frequent complication among patients who receive radiotherapy (RT) . The prevalence of xerostomia has been reported to be from 73.5% to 93% (Kakoei S.,2012). Damage to normal tissues can result by radiotherapy as it is not selective to cancer cells, and so affecting the quality of life of patients. Honey is one of the methods studied by CIM for management of HNC treatment side effects due to its properties. (Brennan et al., 2002; Clarkson et al., 2007; Furness et al., 2011;Hackett et al., 2015).
Thyme honey is a new alternative for management of xerostomia, which is a propolis gel product. Thyme honey is a variety of monofloral honey made from the nectar and pollen of thyme flowers. It has a strong antioxidant, antibacterial, antifungal and immuno modulating health effects. Due to the high sugar concentration in honey, it is believed that its presence in the oral cavity has a sialogogue effect, stimulating the salivary glands to produce saliva.
Detailed description
90 post radiation cancer patients were randomly assigned into two equal groups.The intervention group will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. Patients in the control arm followed the same protocol with normal saline rinses. The treatment assessment of subjective dry mouth score, objective dry mouth score, salivary Ph and salivary flow rate will be carried out at baseline, 2 weeks and one month after starting of the treatment protocol (Charalambous et al., 2017).
Nitric oxide levels will be measured at baseline and after one month of treatment (Abadi et al., 2020).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thyme honey | Experimental | Drug: thyme honey mouth rinseoral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017) |
| Saline | Active comparator | Drug: saline mouth rinseoral rinses with saline 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients referred to non-palliative head and neck radiotherapy
- Total dose of radiation received (50-70 Gy)
- Patients with complaint of xerostomia
- Age 25-65 years old
- Objective dry mouth score from ( 2-5)
Key exclusion criteria (5 listed)
- Have confirmed systemic diseases or medications associated with xerostomia
- Have a known allergy to honey
- Patients who had salivary glands removal surgery
- Patients with salivary gland diseases or malignancy
- Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyme honey mouth rinseoral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017) | Drug | thyme honey |
| saline mouth rinsesaline mouth rinse 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy | Drug | Saline |
Primary outcome
subjective dry mouth score
Time frame: change from baseline at 4 weeks
Q1. Do you feel dryness in your mouth ? Q2. Do you drink liquids to help you swallow dry food? Q3. Do you feel mouth dryness when eating a meal? Q4. Does the saliva seem to be too little in your mouth? Subjects who answered confirmatively to at least one of those questions related to dry mouth will be considered as positive for oral dryness subjective complaints.
4 secondary outcomes
objective dry mouth score
Time frame: change from baseline at 4 weeks
salivary PH
Time frame: change from baseline at 4 weeks
nitric oxide levels
Time frame: change from baseline at 4 weeks
Salivary flow rate
Time frame: change from baseline at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Seif, professor study director
faculty of dentistry- Ain Shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing thyme honey mouth rinse and saline mouth rinse in people with Head and Neck Cancer Patients, run by Ain Shams University at 1 site in Egypt.
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 8 inclusion and 5 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 29 Sep 2025. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
subjective dry mouth score (time frame: change from baseline at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.