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IRCT2015050622132N1 IRCT 2015-08-25 Mashhad University of Medical Sciences evaluation of silymarin effects in prevention and treatment of mucositis induced by radiotherapy of head and neck evaluation of silymarin effects in prevention and treatment of mucositis induced by radiotherapy of head and neck 2014-03-20 anticipated 80 Complete https://irct.ir/trial/19166 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 3 mucositis. Intervention 1: Livergol 140 mg three tablets daily (produced Goldaro), oral, for 6 weeks. Intervention 2: placebo of livergol 140mg, three tablet daily, for 6 week, oral. Intervention 3: three mililiter of nano-silimarine syrup (140mg/cc), for 6 weeks, oral. Intervention 4: placebo of nano-silimarine syrup, 3cc/day, for 6 weeks, oral. http://onlinelibrary.wiley.com/doi/10.1002/ptr.5704/abstract;jsessionid=32FC289236BCC0BBC4553B25A03682A9.f02t01 Background: Mucositis is a frequent severe complication of radiation therapy in patient with head and neck cancer. . Silymarin is a polyphenolic flavonoid extracted from the milk thistle exhibits a strong antioxidant and anti-inflammatory activities. In this study, we evaluate silymarin efficacy in prevention of radiotherapy induced mucositis in patients with head and neck cancer as the first human study.<br /> Methods: During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of oral silymarin 420mg daily in three divided doses starting at the first day of radiotherapy session and continuing for six weeks on oral mucositis occurrence were assessed. Twenty-seven patients, that fulfilled the inclusion criteria assigned to the silymarin or placebo group. World health organization (WHO) and national cancer institute-common terminology criteria (NCI-CTC) oral mucositis grading scale scores were recorded at baseline and weekly during this 6weeks. <br /> Results: The median WHO and NCI-CTC scores was significantly lower in silymarin group at the end of the first to sixth week (P
public Mohammadreza Niazi moghadam
School of Pharmacy, Vakilabad Blvd.
Mashhad Iran (Islamic Republic of) +98 915 186 6103 niazimr891@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
School of Pharmacy, Vakilabad Blvd.
Mashhad Iran (Islamic Republic of) +98 915 517 3808 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria :age between 18 and 60, Patients treated with radiation therapy in head and neck; Radiation dose : 50-70 G; At least half of Oral cavity in the radiation exposure exclusion criteria:Liver failure(Because of the clearance of drugs) if ALT and AST level be more than two to three times higher than the upper limit normal at the beginning of treatment tgat patient will be excluded; Renal failure:GFR <50 ml / min; Severe infection requiring antibiotic therapy; Corticosteroids; pevious history of radiation therapy; patient unsatisfaction; A history of allergy to silymarin. 18 years 65 years Both K12.3 Oral mucositis (ulcerative) Treatment - Drugs Placebo Treatment - Drugs Placebo Livergol 140 mg three tablets daily (produced Goldaro), oral, for 6 weeks placebo of livergol 140mg, three tablet daily, for 6 week, oral three mililiter of nano-silimarine syrup (140mg/cc), for 6 weeks, oral placebo of nano-silimarine syrup, 3cc/day, for 6 weeks, oral Oral Mucositis Assessment Scale. Timepoint: The first week after the intervention, after the intervention of the second week, third week after the intervention, after the intervention of the fourth week, the fifth week after the intervention, after six weeks of intervention. Method of measurement: interviews and Observation. Visual analogue scale. Timepoint: The first week after the intervention, after the intervention of the second week, third week after the intervention, after the intervention of the fourth week, the fifth week after the intervention, after six weeks of intervention. Method of measurement: visual pain scale. Hepatic transaminase levels. Timepoint: Beginning of the study, the first week, second week, third week, four weeks, five weeks, six weeks. Method of measurement: laboratory. Serum creatinine level. Timepoint: Beginning of the study, the first week, second week, third week, four weeks, five weeks, six weeks. Method of measurement: laboratory. Mashhad University of Medical Sciences Approved 2014-10-25 Committee for Medical Research Ethics Central Organization of University, Daneshgah St, Mashhad, Iran Mashhad - Iran Iran (Islamic Republic of)