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Contemp Clin Trials. 2015 Jul;43:33-8. doi: 10.1016/j.cct.2015.04.015. Epub 2015 May 8.

An exercise trial targeting African-American women with metabolic syndrome and at high risk for breast cancer: Rationale, design, and methods.

Author information

1
Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States. Electronic address: cd422@georgetown.edu.
2
Georgetown Lombardi Comprehensive Cancer Center Biostatistics & Bioinformatics Shared Resource, Washington, D.C., United States.
3
Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States.
4
Howard University Cancer Center, Howard University, Washington, D.C., United States.

Abstract

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.

CLINICAL TRIAL REGISTRATION NUMBER:

NCT02103140.

KEYWORDS:

African-American; Breast cancer; Clinical trial; Metabolic syndrome; Physical activity; Randomized controlled trial

PMID:
25962889
PMCID:
PMC4522388
DOI:
10.1016/j.cct.2015.04.015
[Indexed for MEDLINE]
Free PMC Article

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