Prevention of Radiation-induced Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy : A Double-blind Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiation- Induced Mucositis
- Sponsor
- Chulabhorn Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change of mucositis grading
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial
Detailed Description
To compare the effect of each herb extracts in form of mouth wash to protect or delay the onset of the radiation-induced mucositis from the adverse effects of radiation therapy in patients with head and neck cancer.
Investigators
Sirikorn Rojthamarat
Principle Investigator
Chulabhorn Hospital
Eligibility Criteria
Inclusion Criteria
- •Aged 15 years old or older,
- •Diagnosed with Head and Neck cancer
- •On treatment of external Radiation therapy
Exclusion Criteria
- •Previously underwent external Radiation therapy
- •Illiterate
Outcomes
Primary Outcomes
Change of mucositis grading
Time Frame: Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy
RTOG (Radiation Therapy Oncology Group) Grade0: none Grade 1 : oral soreness, erythema Grade 2 : oral erythema, ulcer, solid diet tolerated Grade 3 : oral ulcers, liquid diet only Grade 4 : oral alimentation impossible
Secondary Outcomes
- Patient satisfaction with the mouth wash(The last fraction of radiation therapy, through study completion, an average of 1 year)