The evaluation of the effect of oral melatonin in the treatment of oral mucositis and oral pain reduction in patients with upper gastrointestinal tract tumors
Phase 2
- Conditions
- oral mucositis and oral pain in patients with upper gastrointestinal tract tumors.
- Registration Number
- IRCT20220426054666N1
- Lead Sponsor
- Karaj University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
Age over 18 years
Not anticoagulated
No history of seizure
No history of dementia
No history of depression
No history of diabetes
Signing the informed consent form
Patients with gastric or esophageal cancer that is under treatment with a f-FU-containing regimen and have developed grade 1 or 2 oral mucositis according to the WHO classification
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mucositis severity according to WHO classification and severity of patient oral pain according to common terminology criteria for adverse events (CTCAE) version 5.0 and Visual Analog Scale. Timepoint: Daily. Method of measurement: WHO scale for oral mucositis ,common terminology criteria for adverse events (CTCAE) version 5.0 ,Visual Analog Scale.
- Secondary Outcome Measures
Name Time Method Quality of life. Timepoint: daily. Method of measurement: European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC).