title: An exercise trial to reduce cancer related fatigue in African American breast cancer patients undergoing radiation therapy: Design, rationale, and methods.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
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: Department of Radiation Oncology, Medstar Washington Hospital Center, Washington, D.C., United States.
authors.forename: Pamela D
authors.initials: PD
authors.lastname: Randolph-Jackson
authors.affiliation: Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States.
authors.forename: Claudine
authors.initials: C
authors.lastname: Isaacs
authors.affiliation: Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States.
authors.forename: Mary
authors.initials: M
authors.lastname: Mills
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: Vivian V
authors.initials: VV
authors.lastname: Watkins
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: D000293:Adolescent; D000328:Adult; D001741:Black or African American; D000368:Aged; D001943:Breast Neoplasms / Q000150:complications / Q000208:ethnology / Q000532:radiotherapy*; D002985:Clinical Protocols; D005081:Exercise Therapy / Q000379:methods*; D005221:Fatigue / Q000209:etiology / Q000628:therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011832:Radiation Injuries / Q000628:therapy*; D012107:Research Design; D055815:Young Adult
keywords: African–American; Breast cancer; Clinical trial; Physical activity; Radiotherapy