title: An exercise trial targeting African-American women with metabolic syndrome and at high risk for breast cancer: Rationale, design, and methods.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT02103140.
authors.affiliation: Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States. Electronic address: cd422@georgetown.edu.
authors.forename: Chiranjeev
authors.initials: C
authors.lastname: Dash
authors.affiliation: Georgetown Lombardi Comprehensive Cancer Center Biostatistics & Bioinformatics Shared Resource, Washington, D.C., United States.
authors.forename: Kepher
authors.initials: K
authors.lastname: Makambi
authors.affiliation: Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States.
authors.forename: Sherrie F
authors.initials: SF
authors.lastname: Wallington
authors.affiliation: Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Sheppard
authors.affiliation: Howard University Cancer Center, Howard University, Washington, D.C., United States.
authors.forename: Teletia R
authors.initials: TR
authors.lastname: Taylor
authors.affiliation: Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Hicks
authors.affiliation: Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States.
authors.forename: Lucile L
authors.initials: LL
authors.lastname: Adams-Campbell
mesh_terms: D001741:Black or African American; D014408:Biomarkers, Tumor; D001786:Blood Glucose; D001794:Blood Pressure; D001943:Breast Neoplasms / Q000208:ethnology / Q000517:prevention & control*; D015444:Exercise; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood; D024821:Metabolic Syndrome / Q000208:ethnology / Q000517:prevention & control*; D008875:Middle Aged; D009765:Obesity / Q000208:ethnology / Q000628:therapy*; D017698:Postmenopause; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D014481:United States; D055105:Waist Circumference
chemical_list: D014408:Biomarkers, Tumor; D001786:Blood Glucose; D008055:Lipids
keywords: African-American; Breast cancer; Clinical trial; Metabolic syndrome; Physical activity; Randomized controlled trial