This study is a prospective, double-blind, randomized Clinical trial to compare the effects of silymarin consumed orally with placebo, on the prevention and treatment of oral mucositis caused by radiation therapy. In this study, 80 patients in the Department of Oncology OMID Hospital School of Medicine, Mashhad, after starting radiation therapy due to tumor diagnosis have been selected based on random numbers have been divided into one of four treatment groups where in one group they supposed to consume usual tablet, in another one, they used placebo tablet, in third group they have been described liquid form containing silymarin and in fourth group, placebo Nanomicell.
Patients in the treatment group with description of Livergol 140 mg three tablets daily (produced Goldaro) or three cc of a solution containing Nanomicell form silymarin which contains 140 mg of silymarin per cc. In the placebo group, they used tablets developed by the same factory which looks identical to Livergol and contains all the ingredients, except the active ingredient pharmaceutical, three pills per day. Patients in all four groups for 6 Week (33 to 30 sessions of radiation therapy is active 5 days a week) with a 6 MV linear accelerator radiation therapy will be (dose in each of the four groups varies between 70-50 Gy) to the drug or placebo, in order to prevent mucositis and radiation therapy to determine its efficacy in the treatment of ulcers in patients with oral mucositis caused by radiation therapy. Radiation therapy continue to the end of this location. In addition, examination of patients with tongue blade and flashlight on the first day of radiation therapy, before radiation and subsequent visits every week until the end of the study has been done. If oral lesions based on the standard CTC NCI v.2 and OMAS (oral mucositis assessment scale) to evaluate oral mucositis are used, they have been graded and finally have been compared the criteria used in the study.