Head and Neck Cancer (H&Amp;Amp;N)CoolRinseHNCNCT07252557
Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy
A study testing Water Rinse at Different Temperatures in people with Head and Neck Cancer (H&Amp;Amp;N) and Radiation-induced Oral Mucositis, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Head and Neck Cancer (H&Amp;Amp;N), Radiation-induced Oral Mucositis, Supportive Care
- What is being tested?
- Water Rinse at Different Temperatures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non-HNC diagnoses or radiotherapy to sites outside the oral/oropharyngeal region.
- Cognitive impairment or inability to complete the rinsing protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Different Mouthwash Temperatures on Oral Mucositis Pain and Patient Comfort During Radiotherapy for Head and Neck Cancer: A Randomized Controlled 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.
Read the 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.
- Conditions
- Head and Neck Cancer (H&Amp;Amp;N), Radiation-induced Oral Mucositis, Supportive Care, Nursing Interventions, Radiotherapy Side Effects
- Being tested
- Water Rinse at Different Temperatures
- Keywords
- Head and Neck Cancer, Radiation-Induced Oral Mucositis, Water Temperature, Cold Water Rinse, Supportive Care, Pain Management, Radiotherapy, Nursing Intervention
- Medical subject headings
- Head and Neck Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Rinse at Different TemperaturesBehavioural
rinse their mouth with cold water at approximately 15-20°C
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Water Rinse at Different Temperatures |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Mucositis Severity
Assessed using WHO Oral Mucositis Grading Scale (0-4).
Measured: 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).
Measured: Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy
Secondary outcomes (3)
Oral Comfort
Assessed using a 5-point Likert comfort scale.
Measured: Baseline, Week 2, Week 4, Week 6 (end of radiotherapy)
Satisfaction with Rinsing Modality
Satisfaction questionnaire evaluating acceptability of assigned water temperature.
Measured: 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).
Measured: Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&Amp;Amp;N)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252557
- Sponsor's protocol ID
- 2025-CS2-25178
- Acronym
- CoolRinseHNC
- Status last verified
- Jul 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Mouthwash Temperatures on Oral Mucositis Pain and Patient Comfort During Radiotherapy for Head and Neck Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07252557
- Acronym / sponsor ID
- CoolRinseHNC / 2025-CS2-25178
- Conditions
- Head and Neck Cancer (H&Amp;Amp;N), Radiation-induced Oral Mucositis, Supportive Care, Nursing Interventions, Radiotherapy Side Effects
- Keywords
- Head and Neck Cancer, Radiation-Induced Oral Mucositis, Water Temperature, Cold Water Rinse, Supportive Care, Pain Management, Radiotherapy, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Cold Water Rinse | Experimental | Behavioral: Water Rinse at Different TemperaturesParticipants 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. |
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Non-HNC diagnoses or radiotherapy to sites outside the oral/oropharyngeal region.
- Cognitive impairment or inability to complete the rinsing protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water Rinse at Different Temperaturesrinse their mouth with cold water at approximately 15-20°C | Behavioural | Cold Water Rinse |
Primary outcome
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).
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).
3 secondary outcomes
Oral Comfort
Time frame: Baseline, Week 2, Week 4, Week 6 (end of radiotherapy)
Satisfaction with Rinsing Modality
Time frame: Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy
Psychological Distress
Time frame: Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Rinse at Different Temperatures in people with Head and Neck Cancer (H&Amp;Amp;N) and Radiation-induced Oral Mucositis, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Chun Lee, MD-PhD (+886937355888, lee.yuehchun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.