Multicenter, Phase 3 Trial Comparing Selenium Supplementation With Observation in Gynecologic Radiation Oncology
- Department of Radiotherapy, Lippe Hospital, Lemgo (Germany)
- Institute for Experimental Endocrinology, Charite Berlin, Berlin (Germany)
- Department of Radiotherapy, Central Hospital, Suhl (Germany)
- Department of Radiotherapy, Municipal Hospital, Neubrandenburg (Germany)
- Department of Radiotherapy, Municipal Hospital, Chemnitz (Germany)
- Department of Radiotherapy, Municipal Hospital, Weiden in der Oberpfalz (Germany)
- Department of Otolaryngology, Suedharz Hospital, Nordhausen (Germany)
- Institute of Medical Informatics and Biometry, University Rostock, Rostock (Germany)
- Department of Radiotherapy, St. Josefs Hospital, Wiesbaden (Germany)
- Department of Radiotherapy, Regional Hospital, Feldkirch (Austria)
- biosyn Arzneimittel GmbH, Fellbach (Germany)
- Department of Internal Medicine, St. Anna Hospital, Herne (Germany)
- Department of Radiotherapy and Special Oncology, Medical School, Hannover (Germany)
- Department of Radiotherapy, Muenster University Hospital, Muenster (Germany)
- Department of Radiotherapy and Radiation Oncology, Franziskus Hospital, Bielefeld (Germany)
Purpose: We assessed whether adjuvant supplementation with selenium improves the selenium status and reduces side effects of patients treated by radiotherapy (RT) for cervical and uterine cancer. Methods and Materials: Whole-blood selenium concentrations were measured in patients with cervical cancer (n = 11) and uterine cancer (n = 70) after surgical treatment, during RT, at the end of RT, and 6 weeks after RT. Patients with initial selenium concentrations of less than 84{mu}g/L were randomized before RT either to receive 500 {mu}g of selenium (in the form of sodium selenite [selenase (registered) , biosyn Arzneimittel GmbH, Fellbach, Germany]) by mouth on the days of RT and 300 {mu}g of selenium on the days without RT or to receive no supplement during RT. The primary endpoint of this multicenter Phase 3 study was to assess the efficiency of selenium supplementation during RT; the secondary endpoint was to decrease radiation-induced diarrhea and other RT-dependent side effects. Results: A total of 81 patients were randomized. We enrolled 39 in the selenium group (SG) and 42 in the control group (CG). Selenium levels did not differ between the SG and CG upon study initiation but were significantly higher in the SG at the end of RT. The actuarial incidence of diarrhea of Grade 2 or higher according to Common Toxicity Criteria (version 2) in the SG was 20.5% compared with 44.5% in the CG (p = 0.04). Other blood parameters, Eastern Cooperative Oncology Group performance status, and self-reported quality of life were not different between the groups. Conclusions: Selenium supplementation during RT is effective in improving blood selenium status in selenium-deficient cervical and uterine cancer patients and reduces the number of episodes and severity of RT-induced diarrhea.
- OSTI ID:
- 21438015
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 78, Issue 3; Other Information: DOI: 10.1016/j.ijrobp.2009.08.013; PII: S0360-3016(09)02962-9; Copyright (c) 2010 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
Similar Records
Effects of Probiotic Lactobacillus Casei DN-114 001 in Prevention of Radiation-Induced Diarrhea: Results From Multicenter, Randomized, Placebo-Controlled Nutritional Trial
The Significance of Tumoral ERCC1 Status in Patients With Locally Advanced Cervical Cancer Treated With Chemoradiation Therapy: A Multicenter Clinicopathologic Analysis