Dash Chiranjeev, Randolph-Jackson Pamela D, Isaacs Claudine, Mills Mary, Makambi Kepher, Watkins Vivian V, Adams-Campbell Lucile L
Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C., United States.
Department of Radiation Oncology, Medstar Washington Hospital Center, Washington, D.C., United States.
Contemp Clin Trials. 2016 Mar;47:153-7. doi: 10.1016/j.cct.2016.01.004. Epub 2016 Jan 18.
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.
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.
癌症相关疲劳（CRF）是乳腺癌患者放疗常见且使人衰弱的副作用。体育活动干预可减轻CRF，但缺乏针对非裔美国乳腺癌女性的相关证据。
方法/设计：“佩德lar”研究是一项为期8周的前瞻性结构化中等强度运动干预，与放疗同时进行，旨在减轻非裔美国乳腺癌患者的CRF并改善健康相关生活质量。40名计划在MedStar华盛顿医院中心接受放射治疗的非裔美国乳腺癌女性将被随机分配到两个试验组之一：1）使用便携式固定脚踏运动器进行基于设施的有氧运动；2）对照组。干预组参与者将在放疗前或放疗后在医院进行锻炼。将在基线、第4周和第8周进行评估。结果变量包括CRF、炎症生物标志物和健康相关生活质量。
“佩德lar”研究将提供初步证据，证明短期中等强度运动干预是否可能有效减轻接受乳腺癌放疗的非裔美国女性的CRF，以及这种效果是否由炎症介导。
