Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients

Study Overview
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Brief Summary
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The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy induced oral mucositis and xerostomia and improving quality of life in head and neck cancer patients. This is a randomized, double-blind, placebo controlled trial conducted in head and neck cancer patients. Mixed-block randomization is used to divide eligible patients into two groups: melatonin 40 mg or matched placebo. The patients are required to take the studied drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5 fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H&N), pain (VAS 0-10) and adverse event frequency.

Official Title
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Topical and Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis and Xerostomia in Head and Neck Cancer Patients

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Melatonin
* Drug: Matched Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New diagnostic of head and neck cancer patient who need treatment with radiation involved with the oral cavity area. Never received radiotherapy or chemotherapy Karnofsky performance status > 70% Stopped smoking Able to eat and swallow medications Written informed consent Exclusion Criteria: Melatonin allergy Active oral cavity inflammation scar Pregnancy Creatinine clearance < 30 ml/min Active periodontal disease Steroids or pain killer drugs used for oral cavity pain except NSAIDs for thromboembolism prevention Currently use benzydamine mouthwash

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Matched placebo<br>Drug: match placebo Drug: placebo suspension gargle for 2 minutes before radiation 15 minutes and placebo gelatin capsule taken orally after 21:00 hours each night throughout the study | Drug: Matched Placebo<br>* Drug: Melatonin 20 mg/ 10 ml placebo suspension gargle for 2 minutes before radiation 15 minutes and 20 mg placebo gelatin capsule taken orally after 21:00 hours each night throughout the study<br>* Other names: 20 mg placebo gelatin capsule;|
| Active Comparator: Melatonin<br>Drug: Melatonin 20 mg/ 10 ml melatonin suspension gargle for 2 minutes before radiation 15 minutes and 20 mg melatonin gelatin capsule taken orally after 21:00 hours each night throughout the study | Drug: Melatonin<br>* Drug: Melatonin 20 mg/ 10 ml melatonin suspension gargle for 2 minutes before radiation 15 minutes and 20 mg melatonin gelatin capsule taken orally after 21:00 hours each night throughout the study<br>* Other names: 20 mg melatonin gelatin capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of occurrence of mucositis level 3 or more by using the criteria of CTCAE version 4.0, World Health Organization scale and MTSscores | Participants will be followed for severity of mucositis during the treatment period of 7 weeks | Time to event (occurence of mucositis level 3) during 7 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of occurrence of xerostomia level 2 or more by using the criteria of CTCAE version 4.0 and the Visual Analogue Scale | Participants will be followed for severity of xerostomia during the treatment period of 7 weeks | Time to event (occurence of mucositis level 3) during 7 weeks of treatment | 
| Quality of Life (FACT- H&N Version 4) |  | Change from baseline in Trial Outcome Index scores at 7th week |