Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy

NCT ID: NCT07252557

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-03-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Water Rinse at Different Temperatures

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Water Rinse at Different Temperatures

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chung Shan Medical University

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

Countries

Taiwan

Central Contacts

Yueh-Chun Lee, MD-PhD

Role: CONTACT

lee.yuehchun@gmail.com

+886937355888

Other Identifiers

2025-CS2-25178

Identifier Type: -

Identifier Source: org_study_id