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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold Water Rinse | Experimental | 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. |
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| Room Temperature Water Rinse | No Intervention | Participants will rinse their mouth with room-temperature water at approximately 30-35°C, with identical frequency and duration as the experimental arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water Rinse at Different Temperatures | Behavioral | rinse their mouth with cold water at approximately 15-20°C |
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| Measure | Description | Time Frame |
|---|---|---|
| Oral Mucositis Severity | Assessed using WHO Oral Mucositis Grading Scale (0-4). | 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) | Patient-reported pain intensity using VAS (0-10). | Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Comfort | Assessed using a 5-point Likert comfort scale. | Baseline, Week 2, Week 4, Week 6 (end of radiotherapy) |
| Satisfaction with Rinsing Modality | Satisfaction questionnaire evaluating acceptability of assigned water temperature. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueh-Chun Lee, MD-PhD | Contact | +886937355888 | lee.yuehchun@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University | Taichung | Taiwan (r.o.c.) | Taiwan |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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Parallel Assignment
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| Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy |
| Psychological Distress | Psychological distress measured using the Brief Symptom Rating Scale (BSRS-5). | Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy) |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |