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IRCT2016110730621N1 IRCT 2017-01-02 Mashhad University of Medical Sciences evaluation of topical silymarin on dermal side effect induced by capecitabine in patients with gastrointestinal cancers Evaluation of efficacy of topical formulation of silymarin in prevention and management of hand-foot syndrome induced by capecitabine in patients with gastrointestinal malignancies 2016-02-09 anticipated 40 Complete https://irct.ir/trial/24268 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 3 Hand-foot syndrome. 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. Intervention 2: 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.
public Dr Mohsen Tafaghodi
Vakil Abad- E-Campus University of Mashhad-Iran
Mashhad Iran (Islamic Republic of) 94159-45344 +98 915 584 5302 tafaghodim@mums.ac.ir Mashhad University of Medical Science-Pharmacy faculty scientific Sepideh Elyasi
School of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) +98 51 3882 3255 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 70 years Both R21 Rash and other nonspecific skin eruption 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. 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. 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. Mashhad University of Medical Sciences Approved 2016-10-31 Ethics committe of Mashhad University of Medical Science Ghoreishi building, daneshgah street mashhad Iran (Islamic Republic of)