An interventional study of Water Rinse at Different Temperatures in Head and Neck Cancer (H&Amp;Amp;N), Radiation-induced Oral Mucositis and Supportive Care, sponsored by Chung Shan Medical University. Not yet recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Supportive care
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.
Radiation-induced oral mucositis (RTOM) is a frequent and debilitating side effect of radiotherapy for head and neck cancer, leading to pain, nutritional compromise, and potential treatment discontinuation. Cryotherapy and local temperature modulation have been proposed as low-cost, accessible nursing interventions that reduce inflammation through vasoconstriction and analgesia. This randomized trial will assess the clinical efficacy and patient acceptability of temperature-modulated water rinsing as a non-pharmacologic, supportive-care intervention. Subgroup analyses will examine differential responses among patients with dental sensitivity or betel-nut chewing habits.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 200 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Participants will rinse their mouth with cold water at approximately 15-20°C, four times daily for 30-60 seconds throughout six weeks of radiotherapy, followed by a two-week follow-up period.
Behavioral: Water Rinse at Different Temperatures
Participants will rinse their mouth with room-temperature water at approximately 30-35°C, with identical frequency and duration as the experimental arm.
rinse their mouth with cold water at approximately 15-20°C
Oral Mucositis Severity
Assessed using WHO Oral Mucositis Grading Scale (0-4).
Time frame: Baseline (prior to radiotherapy), Week 2, Week 4, Week 6 (end of radiotherapy), and 2 weeks after completion of radiotherapy
Pain Intensity (VAS 0-10)
Patient-reported pain intensity using VAS (0-10).
Time frame: Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy
Oral Comfort
Assessed using a 5-point Likert comfort scale.
Time frame: Baseline, Week 2, Week 4, Week 6 (end of radiotherapy)
Satisfaction with Rinsing Modality
Satisfaction questionnaire evaluating acceptability of assigned water temperature.
Time frame: Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy
Psychological Distress
Psychological distress measured using the Brief Symptom Rating Scale (BSRS-5).
Time frame: Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy)
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Chung Shan Medical University