Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy (CoolRinseHNC)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Supportive Care; Radiation-induced Oral Mucositis; Radiotherapy Side Effects; Nursing Interventions; Head and Neck Cancer (H&Amp;Amp;N)
• Intervention / Treatment: Behavioral: Water Rinse at Different Temperatures

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueh-Chun Lee, MD-PhD; Phone Number: +886937355888; Email: lee.yuehchun@gmail.com

Study Locations

• Taiwan
  • Taiwan (r.o.c.)
    • Taichung, Taiwan (r.o.c.), Taiwan
      • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cold Water Rinse; 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; rinse their mouth with cold water at approximately 15-20°C
No Intervention: Room Temperature Water Rinse; Participants will rinse their mouth with room-temperature water at approximately 30-35°C, with identical frequency and duration as the experimental arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Mucositis Severity	Assessed using WHO Oral Mucositis Grading Scale (0-4).	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).	Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Comfort	Assessed using a 5-point Likert comfort scale.	Baseline, Week 2, Week 4, Week 6 (end of radiotherapy)
Satisfaction with Rinsing Modality	Satisfaction questionnaire evaluating acceptability of assigned water temperature.	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).	Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy)

Collaborators and Investigators

• Sponsor: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Radiotherapy; Supportive Care; Pain Management; Nursing Intervention; Radiation-Induced Oral Mucositis; Water Temperature; Cold Water Rinse
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Head and Neck Neoplasms; Agnosia
• Other Study ID Numbers: 2025-CS2-25178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No