Hand-foot syndrome. Rash and other nonspecific skin eruption
Conditions
Interventions
Intervention 1: Silymarin topical gel 1% which produced by Goldaru Company, two times a day, one finger tip unit for soles of foots and half of a finger tip unit for soles of the hands for 9 weeks. In
Prevention
Placebo
Silymarin topical gel 1% which produced by Goldaru Company, two times a day, one finger tip unit for soles of foots and half of a finger tip unit for soles of the hands for 9 weeks.
placebo gel of silymarin which produced by Goldaru company, two times a day, one finger tip unit for soles of foots and half of a finger tip unit for soles of the hands for 9 weeks.
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Mohsen Tafaghodi
Mashhad University of Medical Science-Pharmacy faculty
Outcome results
None listed