Clinical trial · Interventional
Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients
Topical and Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis and Xerostomia in Head and Neck Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Matched Placebo | Drug | — | UNRESOLVED |
| Melatonin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Matched placebo
- description
- 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
- interventionNames
- Drug: Matched Placebo
- type
- ACTIVE_COMPARATOR
- label
- Melatonin
- description
- 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
- interventionNames
- Drug: Melatonin
Primary outcomes (1)
- measure
- Percentage of occurrence of mucositis level 3 or more by using the criteria of CTCAE version 4.0, World Health Organization scale and MTSscores
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available