Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy

NCT07252557 — Not applicable, Not yet recruiting, 200 participants, Chung Shan Medical University

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Effectiveness of Different Mouthwash Temperatures on Oral Mucositis Pain and Patient Comfort During Radiotherapy for Head and Neck Cancer: A Randomized Controlled Trial

Registry	NCT07252557, acronym CoolRinseHNC
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	200 (Estimated)
Sponsor	Chung Shan Medical University (Other)
Conditions	Head and Neck Cancer (H&Amp;Amp;N), Radiation-induced Oral Mucositis, Supportive Care, Nursing Interventions, Radiotherapy Side Effects
Interventions	Water Rinse at Different Temperatures (Behavioral)
Dates	start 2026-01-01 (estimated), primary completion 2026-12-31 (estimated), completion 2027-03-31 (estimated), first posted 2025-11-26, last updated 2025-11-26
Locations	1 site in Taiwan

-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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Cold Water Rinse	Experimental	Behavioral: Water Rinse at Different Temperatures	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.
Room Temperature Water Rinse	No intervention		Participants will rinse their mouth with room-temperature water at approximately 30-35°C, with identical frequency and duration as the experimental arm.

Water Rinse at Different Temperatures (Behavioral): rinse their mouth with cold water at approximately 15-20°C

+Outcome measures

Primary outcomes

Oral Mucositis Severity [Baseline (prior to radiotherapy), Week 2, Week 4, Week 6 (end of radiotherapy), and 2 weeks after completion of radiotherapy]: Assessed using WHO Oral Mucositis Grading Scale (0-4).
Pain Intensity (VAS 0-10) [Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy]: Patient-reported pain intensity using VAS (0-10).

Secondary outcomes

Oral Comfort [Baseline, Week 2, Week 4, Week 6 (end of radiotherapy)]: Assessed using a 5-point Likert comfort scale.
Satisfaction with Rinsing Modality [Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy]: Satisfaction questionnaire evaluating acceptability of assigned water temperature.
Psychological Distress [Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy)]: Psychological distress measured using the Brief Symptom Rating Scale (BSRS-5).

+Eligibility

Sex: All, ages: 20 Years to 80 Years

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.

+Locations (1)

Facility	City	Country	Status
Chung Shan Medical University	Taichung, Taiwan (r.o.c.)	Taiwan