evaluation of topical silymarin on dermal side effect induced by capecitabine in patients with gastrointestinal cancers
Phase 3
- Conditions
- Hand-foot syndrome.Rash and other nonspecific skin eruption
- Registration Number
- IRCT2016110730621N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
inclusion criteria: age between 18-70 years- gastrointestinal tract malignancies who treated with chemotherapy regimen included capecitabine
exclusion criteria: hepatic failure (LFT >5times of upper limit normal, or >3time of upper limit normal and symptoms), renal failure (GFR<30), severe infection requiring antibiotic therapy, dissatisfaction of patient, history of allergy to silymarin, autoimmune disease history, diabetes mellitus, concomitant use of NSAIDs, corticosteroids, other immunosuppressive drugs
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hand-foot syndorme occurrence. Timepoint: at the begining of the study, at the end of third week after intervention, at the end of 6th week after intervention, and at the end of the 9th weekafter intervention. Method of measurement: grade of the WHO criteria for classification of hand-foot syndrome.
- Secondary Outcome Measures
Name Time Method Hepatic transaminase level. Timepoint: At the beginning of the study, at the end of the third, 6th, and 9th weeks. Method of measurement: laboratory.;Serum creatinine and BUN level. Timepoint: At the beginning of the study, at the end of the third, 6th, and 9th weeks. Method of measurement: laboratory.