Trials / Not Yet Recruiting

Not Yet RecruitingNCT07252557

Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 200 (estimated)

Sponsor: Chung Shan Medical University · Academic / Other
Sex: All
Age: 20 Years – 80 Years
Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Water Rinse at Different Temperatures	rinse their mouth with cold water at approximately 15-20°C

Timeline

Start date: 2026-01-01
Primary completion: 2026-12-31
Completion: 2027-03-31
First posted: 2025-11-26
Last updated: 2025-11-26

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT07252557. Inclusion in this directory is not an endorsement.