An exercise trial to reduce cancer related fatigue in African American breast cancer patients undergoing radiation therapy: Design, rationale, and methods.

BACKGROUND: Cancer related fatigue (CRF) is a common and debilitating side-effect of radiotherapy in breast cancer patients. Physical activity interventions can attenuate CRF but evidence in African-American women with breast cancer is lacking. METHODS/DESIGN: The "Pedlar" Study is a prospective, 8-week structured moderate-intensity exercise intervention, delivered concurrently with radiotherapy, to reduce CRF and improve health-related quality of life among African American breast cancer patients. Forty African American women with breast cancer scheduled to receive radiation therapy at MedStar Washington Hospital Center will be randomized to one of the two trial arms: 1) a facility-based aerobic exercise utilizing a portable stationary pedal exerciser; and 2) a control group. Intervention arm participants will exercise at the hospital either before or after their radiation treatment. Assessments will be conducted at baseline, 4, and 8 weeks. The outcome variables are CRF, biomarkers of inflammation, and health-related quality of life. DISCUSSION: The Pedlar Study will provide preliminary evidence on whether a short-term moderate-intensity exercise intervention might be effective in reducing CRF in African American women undergoing radiotherapy for breast cancer, and whether this effect is mediated by inflammation.