Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy

NCT07252557 | Not Yet Recruiting

• 1 other identifier: 2025-CS2-25178
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer (H&Amp;Amp;N); Radiation-induced Oral Mucositis; Supportive Care; Nursing Interventions; Radiotherapy Side Effects

Keywords

Head and Neck Cancer; Radiation-Induced Oral Mucositis; Water Temperature; Cold Water Rinse; Supportive Care; Pain Management; Radiotherapy; Nursing Intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Oral Comfort

  Baseline, Week 2, Week 4, Week 6 (end of radiotherapy)

• Satisfaction with Rinsing Modality

  Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy

• Psychological Distress

  Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy)

Study Arms (2)

Cold Water Rinse

EXPERIMENTAL

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

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.

Interventions

Water Rinse at Different Temperatures BEHAVIORAL

rinse their mouth with cold water at approximately 15-20°C

Cold Water Rinse

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non-HNC diagnoses or radiotherapy to sites outside the oral/oropharyngeal region.
• Cognitive impairment or inability to complete the rinsing protocol.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, Taiwan (r.o.c.), Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yueh-Chun Lee, MD-PhD

CONTACT

+886937355888; lee.yuehchun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)