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Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy

ConditionsHead and Neck Cancer (H&Amp;Amp;N)Radiation-induced Oral MucositisSupportive CareNursing InterventionsRadiotherapy Side Effects
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChung Shan Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Non-HNC diagnoses or radiotherapy to sites outside the oral/oropharyngeal region.

Cognitive impairment or inability to complete the rinsing protocol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Water Rinse at Different Temperatures

    Behavioral

    rinse their mouth with cold water at approximately 15-20°C

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Cold Water RinseExperimental treatment 1 intervention
Group B: Room Temperature Water RinseNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Oral Mucositis Severity

Assessed using WHO Oral Mucositis Grading Scale (0-4).

Time frame
Baseline (prior to radiotherapy), Week 2, Week 4, Week 6 (end of radiotherapy), and 2 weeks after completion of radiotherapy
2

Pain Intensity (VAS 0-10)

Patient-reported pain intensity using VAS (0-10).

Time frame
Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy

Secondary outcomes

1

Oral Comfort

Assessed using a 5-point Likert comfort scale.

Time frame
Baseline, Week 2, Week 4, Week 6 (end of radiotherapy)
2

Satisfaction with Rinsing Modality

Satisfaction questionnaire evaluating acceptability of assigned water temperature.

Time frame
Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy
3

Psychological Distress

Psychological distress measured using the Brief Symptom Rating Scale (BSRS-5).

Time frame
Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chung Shan Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: