Melatonin for Prevention of Radiation Induced Oral Mucositis (NCT03833570) | Clinical Trial Compass
CompletedPhase 2
Melatonin for Prevention of Radiation Induced Oral Mucositis
Egypt40 participantsStarted 2018-01-12
Plain-language summary
The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.
Who can participate
Age range
25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
* Patients whose radiotherapy treatment planned dose is between 60-70 Gy.
* Patients who had received chemotherapy prior to radiotherapy or are going to receive chemotherapy in concomitant to radiotherapy.
Exclusion Criteria:
* Patients under Anticoagulants such as warfarin, heparin, or aspirin.
* Patients under Fluvoxamine (Luvox) and Nifedipine medications.
* Patients whose radiotherapy treatment planned dose is lower than 60 Gy.
* Pregnant and lactating women.
* Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
* Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in severity of oral mucositis at different time points along the study
Timeframe: up to 3 and 6 weeks
2
Changes in the total antioxidant capacity (TAC) in saliva at different time points along the study