Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy
NCT07252557 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-11-26
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. 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
- Head and Neck Cancer (H&Amp;Amp;N)
- Radiation-induced Oral Mucositis
- Supportive Care
- Nursing Interventions
- Radiotherapy Side Effects
Interventions
- BEHAVIORAL
-
Water Rinse at Different Temperatures
rinse their mouth with cold water at approximately 15-20°C
Sponsors & Collaborators
-
Chung Shan Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-03-31
Countries
- Taiwan
Study Locations
More Related Trials
-
Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.
NCT05341206 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Sodium Bicarbonate for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
NCT06854510 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis
NCT05040425 ·Status: UNKNOWN ·Phase: PHASE2
-
Copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy
NCT06708702 ·Status: WITHDRAWN ·Phase: PHASE2
-
The Effect of Honey on Xerostomia and Oral Mucositis
NCT01465308 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients
NCT03035825 ·Status: COMPLETED ·Phase: NA
-
Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint
NCT06414161 ·Status: RECRUITING ·Phase: NA
-
Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis
NCT06482034 ·Status: COMPLETED ·Phase: PHASE2
-
The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer
NCT06934733 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
NCT02608879 ·Status: COMPLETED ·Phase: NA
-
Using Massage of Maxillofacial and Oral Cavity to Prevent Radioactive Oral Mucositis
NCT03788499 ·Status: COMPLETED ·Phase: NA
-
Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients
NCT02430298 ·Status: COMPLETED ·Phase: PHASE2
-
Prophylactic Oral Vitamin D and Zinc for Radiation-Induced Oral Mucositis in Head and Neck Cancer
NCT06100692 ·Status: NOT_YET_RECRUITING
-
Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer
NCT01653327 ·Status: COMPLETED ·Phase: PHASE2
-
Microbiota and Symptom Distress in Head and Neck Cancer Patients Receiving Radiotherapy
NCT04843644 ·Status: UNKNOWN ·Phase: NA
-
Effects for Oral Mucositis Care During Chemoradiotherapy in Cancer Patients: Evaluation of the Bee Products
NCT05625841 ·Status: UNKNOWN ·Phase: NA
-
N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients
NCT07082621 ·Status: COMPLETED ·Phase: NA
-
Effect of Topical Morphine (Mouthwash) on Oral Pain Due to Chemo- and/or Radiotherapy Induced Mucositis
NCT00613743 ·Status: COMPLETED ·Phase: NA
-
Oral Glutamine and Mucositis of Head and Neck Cancer Patients Undergoing Radiation
NCT02282839 ·Status: UNKNOWN ·Phase: PHASE3
-
The Efficacy of Mouth Exercise in Oral Cancer Patients After Receiving Surgery
NCT05227807 ·Status: COMPLETED ·Phase: NA
-
Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
NCT00004234 ·Status: COMPLETED ·Phase: PHASE3
-
Saliva Substitute Mouthwash in NPC Survivors With Xerostomia: A Randomized Controlled Trial
NCT04491435 ·Status: COMPLETED ·Phase: NA
-
Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma
NCT02945878 ·Status: UNKNOWN
-
The Effect of Hydrogen Water in Oral Mucositis in Head and Neck Cancer Patients After Therapy
NCT05913895 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Evaluation of the Unstimulated Whole Saliva Flow During and After Radiotherapy, With the Use HcT20
NCT00741754 ·Status: COMPLETED ·Phase: PHASE2