Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology
| Autor: | Oliver Micke, Lutz Schomburg, Guenther Stoll, Franz J. Prott, A. DeVries, Dieter Baaske, U. Schaefer, Ralph Muecke, R. Berndt-Skorka, Berthold Reichl, Frank Bruns, M. Glatzel, Norman Willich, Jens Buentzel, Guenter Kundt, Klaus Kisters |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Diarrhea Cancer Research medicine.medical_specialty Time Factors medicine.medical_treatment Phases of clinical research chemistry.chemical_element Uterine Cervical Neoplasms Gastroenterology law.invention Selenium Sodium Selenite Randomized controlled trial Uterine cancer law Selenium deficiency Internal medicine Germany medicine Clinical endpoint Humans Radiology Nuclear Medicine and imaging Aged Cervical cancer Gynecology Aged 80 and over Radiation Radiotherapy business.industry food and beverages Middle Aged medicine.disease Radiation therapy Oncology chemistry Uterine Neoplasms Female business |
| Zdroj: | International journal of radiation oncology, biology, physics. 78(3) |
| ISSN: | 1879-355X |
| Popis: | 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 84μg/L were randomized before RT either to receive 500 μg of selenium (in the form of sodium selenite [selenase®, biosyn Arzneimittel GmbH, Fellbach, Germany]) by mouth on the days of RT and 300 μg 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. |
| Databáze: | OpenAIRE |
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