Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Water Rinse at Different Temperatures.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer (H&Amp;Amp;N), Radiation-induced Oral Mucositis, Supportive Care, Nursing Interventions. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Different Mouthwash Temperatures on Oral Mucositis Pain and Patient Comfort During Radiotherapy for Head and Neck Cancer: A Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral Water Rinse at Different Temperatures
rinse their mouth with cold water at approximately 15-20°C
Primary outcome measures
- Oral Mucositis Severity [Time frame: 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) [Time frame: Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy]
Secondary outcome measures (3)
- Oral Comfort [Time frame: Baseline, Week 2, Week 4, Week 6 (end of radiotherapy)]
- Satisfaction with Rinsing Modality [Time frame: Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy]
- Psychological Distress [Time frame: Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- Chung Shan Medical University — Taichung
Identifiers
NCT: NCT07252557 · 2025-CS2-25178