Radiation- Induced MucositisNCT03359187
Prevention of Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy
A study testing Normal saline with salt/Soda, Clinacanthus nutans and Boesenbergia rotunda in people with Radiation- Induced Mucositis and Adverse Effect of Radiation Therapy, run by Chulabhorn Hospital at 1 site in Thailand.
Trial summary
Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Radiation- Induced Mucositis, Adverse Effect of Radiation Therapy, Head and Neck Cancer
- What is being tested?
- Normal saline with salt/Soda, Clinacanthus nutans and Boesenbergia rotunda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2016to Mar 2018
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 15 years old or older,
- Diagnosed with Head and Neck cancer
- On treatment of external Radiation therapy
Who cannot join
- Pregnant
- Previously underwent external Radiation therapy
- Illiterate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Radiation-induced Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy : A Double-blind Randomized Controlled Trial
Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial
Read the detailed description
To compare the effect of each herb extracts in form of mouth wash to protect or delay the onset of the radiation-induced mucositis from the adverse effects of radiation therapy in patients with head and neck cancer.
- Being tested
- Normal saline with salt/Soda, Clinacanthus nutans, Boesenbergia rotunda
- Keywords
- Radiation- induced mucositis, Head and Neck Cancer, Radiation therapy side effect
- Medical subject headings
- Radiation Injuries, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal saline with salt/SodaOther
Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment
Clinacanthus nutansOther
Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment
Boesenbergia rotundaOther
Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment
| Study group | Role | What they receive |
|---|---|---|
| Normal saline with salt/Soda | Active comparator | Normal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml. Receives: Other: Normal saline with salt/Soda |
| Clinacanthus nutans | Experimental | Clinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml. Receives: Other: Clinacanthus nutans |
| Boesenbergia rotunda | Experimental | Boesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml. Receives: Other: Boesenbergia rotunda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mucositis grading
RTOG (Radiation Therapy Oncology Group) Grade0: none Grade 1 : oral soreness, erythema Grade 2 : oral erythema, ulcer, solid diet tolerated Grade 3 : oral ulcers, liquid diet only Grade 4 : oral alimentation impossible
Measured: Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy
Secondary outcomes (1)
Patient satisfaction with the mouth wash
Scoring 1-4 not satisfied slightly satisfied moderately satisfied very satisfied
Measured: The last fraction of radiation therapy, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study startFeb 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation- Induced MucositisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental design in 3 groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulabhorn Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirikorn Rojthamarat, Chulabhorn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359187
- Sponsor's protocol ID
- 004/2559
- Status last verified
- Aug 2020
- First submitted
- 26 Sep 2016
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Kongwattanakul S, Petchann N, Petroch P, Thanthong S, Tungfung S, Chamchod S, Pitiporn S, Nantajit D. Prophylactic management of radiation-induced mucositis using herbal mouthwash in patients with head and neck cancer: an assessor-blinded randomized controlled trial. J Complement Integr Med. 2022 Feb 28;19(3):771-780. doi: 10.1515/jcim-2021-0457. eCollection 2022 Sep 1.
PubMed 35218685
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Radiation-induced Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy : A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03359187
- Acronym / sponsor ID
- 004/2559
- Keywords
- Radiation- induced mucositis, Head and Neck Cancer, Radiation therapy side effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chulabhorn HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 2 Dec 2017 (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.
Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial
Detailed description
To compare the effect of each herb extracts in form of mouth wash to protect or delay the onset of the radiation-induced mucositis from the adverse effects of radiation therapy in patients with head and neck cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Experimental design in 3 groups
| Arm | Type | Receives |
|---|---|---|
| Normal saline with salt/Soda | Active comparator | Other: Normal saline with salt/SodaNormal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml. |
| Clinacanthus nutans | Experimental | Other: Clinacanthus nutansClinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml. |
| Boesenbergia rotunda | Experimental | Other: Boesenbergia rotundaBoesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 15 years old or older,
- Diagnosed with Head and Neck cancer
- On treatment of external Radiation therapy
Key exclusion criteria (3 listed)
- Pregnant
- Previously underwent external Radiation therapy
- Illiterate
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 |
|---|---|---|
| Normal saline with salt/SodaHead and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment | Other | Normal saline with salt/Soda |
| Clinacanthus nutansHead and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment | Other | Clinacanthus nutans |
| Boesenbergia rotundaHead and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment | Other | Boesenbergia rotunda |
Primary outcome
Change of mucositis grading
Time frame: Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy
RTOG (Radiation Therapy Oncology Group) Grade0: none Grade 1 : oral soreness, erythema Grade 2 : oral erythema, ulcer, solid diet tolerated Grade 3 : oral ulcers, liquid diet only Grade 4 : oral alimentation impossible
1 secondary outcome
Patient satisfaction with the mouth wash
Time frame: The last fraction of radiation therapy, through study completion, an average of 1 year
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 5 Aug 2020.
- Derived from this study: PubMed 35218685Kongwattanakul S, Petchann N, Petroch P, Thanthong S, Tungfung S, Chamchod S, Pitiporn S, Nantajit D. Prophylactic management of radiation-induced mucositis using herbal mouthwash in patients with head and neck cancer: an assessor-blinded randomized controlled trial. J Complement Integr Med. 2022 Feb 28;19(3):771-780. doi: 10.1515/jcim-2021-0457. eCollection 2022 Sep 1.
- Individual participant dataSharing planned: Yes
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Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
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Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
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Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline with salt/Soda, Clinacanthus nutans and Boesenbergia rotunda in people with Radiation- Induced Mucositis and Adverse Effect of Radiation Therapy, run by Chulabhorn Hospital at 1 site in Thailand.
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 3 inclusion and 3 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 5 Aug 2020. 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 Thailand. 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?
Change of mucositis grading (time frame: Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy). 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 NCT03359187, which also lists 1 linked publication.
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 5 Aug 2020.