[Effect of selenium on the side effect profile of adjuvant chemotherapy/radiotherapy in patients with breast carcinoma. Design for a clinical study].

Selenium is a very important component of the antioxidative protective mechanism which belong to every cell. By chemotherapy and radiotherapy a strong increase of free oxygen radicals is induced leading to a damage also of normal tissue. This phenomenon is registered as adverse drug reactions. Since, in addition, tumor patients frequently have low selenium blood levels the application of higher doses of selenium in connection with chemo- and radiotherapy will induce the toxicity of the treatment without lowering the efficiency. Within the presented prospective randomized placebo-controlled double-blind phase-III study we intend to answer the question whether the application of higher doses of sodium selenite will reduce the toxicity of chemotherapy and radiotherapy. Primary targets of the study are therefore the evaluation of toxicity according to CTC-criteria and of life quality.

RCT Entities:   Population Interventions Outcomes