Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer (H&Amp;Amp;N) | Malignant Head and Neck Neoplasm | ALIAS | 0.85 |
| Nursing Interventions | — | UNRESOLVED | — |
| Radiation-induced Oral Mucositis | — | UNRESOLVED | — |
| Radiotherapy Side Effects | — | UNRESOLVED | — |
| Supportive Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Water Rinse at Different Temperatures | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cold Water Rinse
- 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.
- interventionNames
- Behavioral: Water Rinse at Different Temperatures
- type
- NO_INTERVENTION
- label
- Room Temperature Water Rinse
- description
- Participants will rinse their mouth with room-temperature water at approximately 30-35°C, with identical frequency and duration as the experimental arm.
Primary outcomes (2)
- measure
- Oral Mucositis Severity
- timeFrame
- Baseline (prior to radiotherapy), Week 2, Week 4, Week 6 (end of radiotherapy), and 2 weeks after completion of radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available