Journal
CONTEMPORARY CLINICAL TRIALS
Volume 43, Issue -, Pages 33-38Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2015.04.015
Keywords
Clinical trial; Physical activity; Breast cancer; Metabolic syndrome; African-American; Randomized controlled trial
Funding
- NIH/NIMHD grant P60 Center of Excellence for Health Disparities [1P60MD006920-01]
- NIH/NCI [P30 CA051008]
- GHUCCTS grant [UL1TR000101]
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Background: Metabolic syndrome and obesity are known risk factors for breast cancers. Exercise interventions can potentially modify circulating biomarkers of breast cancer risk but evidence in African-Americans and women with metabolic syndrome is lacking. Methods/design: The Focused Intervention on Exercise to Reduce CancEr (FIERCE) trial is a prospective, 6-month, 3-arm, randomized controlled trial to examine the effect of exercise on obesity, metabolic syndrome components, and breast cancer biomarkers among African-American women at high risk of breast cancer. Two hundred-forty inactive women with metabolic syndrome and absolute risk of breast cancer >= 1.40 will be randomized to one of the three trial arms: 1) a supervised, facility-based exercise arm; 2) a home-based exercise arm; and 3) a control group that maintains physical activity levels through the course of the trial. Assessments will be conducted at baseline, 3 months, and 6 months. The primary outcome variables are anthropometric indicators of obesity, metabolic syndrome components, and inflammatory, insulin-pathway, and hormonal biomarkers of breast cancer risk. Discussion: The FIERCE trial will provide evidence on whether a short-term exercise intervention might be effective in reducing breast cancer risk among African-American women with comorbidities and high breast cancer risk - a group traditionally under-represented in non-therapeutic breast cancer trials. (C) 2015 Elsevier Inc. All rights reserved.
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