Investigation of the effect of Melatonin mouthwash on prevention of chemotherapy-induced oral mucositis
Phase 3
- Conditions
- chemotherapy-induced oral mucositis.
- Registration Number
- IRCT20220213054015N1
- Lead Sponsor
- Karaj University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Age 18 and above.
A patient with malignant solid tumor and candidate for chemotherapy (receiving medications with potential of almost similar mucositis: Cyclophosphamide, Doxorubicin, Fluorouracil, Methotrexate, Gemcitabine, Dacarbazine, and Cisplatin).
Karnofsky status = ??%.
Oral and written satisfaction (consent) of patients to participate in survey.
Exclusion Criteria
Inability in using the mouthwash.
Smoking.
Increasing hypersensitivity to melatonin or any other components used in formulation.
History of head and neck radiotherapy.
Having any lesions inside the mouth.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intensity of mucositis. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: World Health Organization Toxicity Scale.
- Secondary Outcome Measures
Name Time Method Intensity of pain. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: Visual analog scale.;Quality of Life. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: EORTC Quality of Life Questionnaire QLQ-C30.