Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-04 @ 6:41 AM
Study NCT ID:
NCT07252557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'Assessed using WHO Oral Mucositis Grading Scale (0-4).'}, {'measure': 'Pain Intensity (VAS 0-10)', 'timeFrame': 'Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy', 'description': 'Patient-reported pain intensity using VAS (0-10).'}], 'secondaryOutcomes': [{'measure': 'Oral Comfort', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6 (end of radiotherapy)', 'description': 'Assessed using a 5-point Likert comfort scale.'}, {'measure': 'Satisfaction with Rinsing Modality', 'timeFrame': 'Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy', 'description': 'Satisfaction questionnaire evaluating acceptability of assigned water temperature.'}, {'measure': 'Psychological Distress', 'timeFrame': 'Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy)', 'description': 'Psychological distress measured using the Brief Symptom Rating Scale (BSRS-5).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Head and Neck Cancer', 'Radiation-Induced Oral Mucositis', 'Water Temperature', 'Cold Water Rinse', 'Supportive Care', 'Pain Management', 'Radiotherapy', 'Nursing Intervention'], 'conditions': ['Head and Neck Cancer (H&Amp;Amp;N)', 'Radiation-induced Oral Mucositis', 'Supportive Care', 'Nursing Interventions', 'Radiotherapy Side Effects']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed head and neck cancer (HNC) receiving radiotherapy for the first time, with or without concurrent chemotherapy.\n* Conscious, communicative, and able to perform the rinsing procedure and complete questionnaires.\n* Provided written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* Non-HNC diagnoses or radiotherapy to sites outside the oral/oropharyngeal region.\n* Cognitive impairment or inability to complete the rinsing protocol.'}, 'identificationModule': {'nctId': 'NCT07252557', 'acronym': 'CoolRinseHNC', 'briefTitle': 'Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Effectiveness of Different Mouthwash Temperatures on Oral Mucositis Pain and Patient Comfort During Radiotherapy for Head and Neck Cancer: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-CS2-25178'}}, 'armsInterventionsModule': {'armGroups': [{'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.'}], 'interventions': [{'name': 'Water Rinse at Different Temperatures', 'type': 'BEHAVIORAL', 'description': 'rinse their mouth with cold water at approximately 15-20°C', 'armGroupLabels': ['Cold Water Rinse']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'state': 'Taiwan (r.o.c.)', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Yueh-Chun Lee, MD-PhD', 'role': 'CONTACT', 'email': 'lee.yuehchun@gmail.com', 'phone': '+886937355888'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}