Clinical Trial

Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy

Study acronym: CoolRinseHNC
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07252557
Lead Sponsor Chung Shan Medical University
Conditions Head and Neck Cancer (H&N), Radiation-induced Oral Mucositis, Supportive Care, Nursing Interventions, Radiotherapy Side Effects
Enrollment 200 participants
Start Date 2026-01-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-26