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

Chung Shan Medical University

Status: Not yet enrolling

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

Treatments: Behavioral: Water Rinse at Different Temperatures

Study type: Interventional

Funder types: Other

Identifiers

NCT07252557

2025-CS2-25178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Cold Water Rinse

Experimental group

Description:

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.

Treatment:

Behavioral: Water Rinse at Different Temperatures

Room Temperature Water Rinse

No Intervention group

Description:

Participants will rinse their mouth with room-temperature water at approximately 30-35°C, with identical frequency and duration as the experimental arm.