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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
rinse their mouth with cold water at approximately 15-20°C
Chung Shan Medical University
Taichung, Taiwan (r.o.c.), Taiwan
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)
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