Head and Neck Cancer (H&Amp;Amp;N), Nursing Interventions, Radiation-induced Oral Mucositis, Radiotherapy Side Effects, Supportive Care
Conditions
Keywords
Head and Neck Cancer, Radiation-Induced Oral Mucositis, Water Temperature, Cold Water Rinse, Supportive Care, Pain Management, Radiotherapy, Nursing Intervention
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.
Interventions
BEHAVIORALWater Rinse at Different Temperatures
rinse their mouth with cold water at approximately 15-20°C
Sponsors
Chung Shan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Mucositis Severity | Baseline (prior to radiotherapy), Week 2, Week 4, Week 6 (end of radiotherapy), and 2 weeks after completion of radiotherapy | Assessed using WHO Oral Mucositis Grading Scale (0-4). |
| Pain Intensity (VAS 0-10) | Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy | Patient-reported pain intensity using VAS (0-10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Comfort | Baseline, Week 2, Week 4, Week 6 (end of radiotherapy) | Assessed using a 5-point Likert comfort scale. |
| Satisfaction with Rinsing Modality | Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy | Satisfaction questionnaire evaluating acceptability of assigned water temperature. |
| Psychological Distress | Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy) | Psychological distress measured using the Brief Symptom Rating Scale (BSRS-5). |
Countries
Taiwan
Contacts
Primary ContactYueh-Chun Lee, MD-PhD
Outcome results
None listed