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NCT Number: NCT07252557

Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy

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.

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Key information

Conditions

Head and Neck Cancer (H&Amp;Amp;N) Agnosia Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nursing Interventions Pathological Conditions, Signs and Symptoms Perceptual Disorders Radiation-induced Oral Mucositis Radiotherapy Side Effects Signs and Symptoms Supportive Care

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, Taiwan (r.o.c.), Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Water Rinse at Different Temperatures

Behavioral

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

Primary outcomes

  1. 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

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

  2. Pain Intensity (VAS 0-10)

    Time frame: 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 outcomes

  1. Oral Comfort

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

    Assessed using a 5-point Likert comfort scale.

  2. Satisfaction with Rinsing Modality

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

    Satisfaction questionnaire evaluating acceptability of assigned water temperature.

  3. Psychological Distress

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yueh-Chun Lee, MD-PhD

CONTACT

[email protected]

+886937355888

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Effectiveness of Different Mouthwash Temperatures on Oral Mucositis Pain and Patient Comfort During Radiotherapy for Head and Neck Cancer: A Randomized Controlled Trial

Acronym: CoolRinseHNC

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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