Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy (NCT07252557) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy
Taiwan200 participantsStarted 2026-01-01
Plain-language summary
This single-center randomized controlled trial evaluates the effects of cold (15-20°C) versus room-temperature (30-35°C) water gargling on oral mucositis severity, pain, and comfort in patients with head and neck cancer undergoing radiotherapy. Participants will rinse their mouth four times daily for 30-60 seconds over a 6-week radiotherapy course, with follow-up for two additional weeks. The study hypothesizes that cold-water rinsing can reduce the severity of radiation-induced oral mucositis (RTOM) and pain, improve oral comfort, and minimize treatment interruptions.
Who can participate
Age range
20 Years – 80 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:
* Histologically confirmed head and neck cancer (HNC) receiving radiotherapy for the first time, with or without concurrent chemotherapy.
* Conscious, communicative, and able to perform the rinsing procedure and complete questionnaires.
* Provided written informed consent prior to enrollment.
Exclusion Criteria:
* Non-HNC diagnoses or radiotherapy to sites outside the oral/oropharyngeal region.
* Cognitive impairment or inability to complete the rinsing protocol.
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
Oral Mucositis Severity
Timeframe: Baseline (prior to radiotherapy), Week 2, Week 4, Week 6 (end of radiotherapy), and 2 weeks after completion of radiotherapy
2
Pain Intensity (VAS 0-10)
Timeframe: Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy