Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods
1 Division of Biokinesiology and Physical Therapy, University of Southern California, 1540 E. Alcazar St. CHP 155, 90089 Los Angeles, CA, USA
2 Division of Medical Oncology and Experimental Therapeutics, City of Hope National Medical Center, 1500 E. Duarte Rd, 91010 Duarte, CA, USA
3 E-488 Van Vliet Center Faculty of Physical Education and Recreation, University of Alberta, Edmonton, Alberta T6G 2H9, Canada
4 Department of Nutrition Sciences, University of Alabama Birmingham, 1675 University Blvd, 35294 Birmingham, AL, USA
5 Division of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, 2250 Alcazar St. Suite 200, 90033 Los Angeles, CA, USA
6 Department of Medicine, Keck School of Medicine, University of Southern California, 1441 Eastlake Ave, 90033 Los Angeles, CA, USA
7 Division of Cancer Etiology, Beckman Research Institute, City of Hope, 1500 E. Duarte Rd, 91010 Duarte, CA, USA
BMC Cancer 2014, 14:238 doi:10.1186/1471-2407-14-238Published: 3 April 2014
Metabolic syndrome (MetS) is increasingly present in breast cancer survivors, possibly worsened by cancer-related treatments, such as chemotherapy. MetS greatly increases risk of cardiovascular disease and diabetes, co-morbidities that could impair the survivorship experience, and possibly lead to cancer recurrence. Exercise has been shown to positively influence quality of life (QOL), physical function, muscular strength and endurance, reduce fatigue, and improve emotional well-being; however, the impact on MetS components (visceral adiposity, hyperglycemia, low serum high-density lipoprotein cholesterol, hypertriglyceridemia, and hypertension) remains largely unknown. In this trial, we aim to assess the effects of combined (aerobic and resistance) exercise on components of MetS, as well as on physical fitness and QOL, in breast cancer survivors soon after completing cancer-related treatments.
This study is a prospective randomized controlled trial (RCT) investigating the effects of a 16-week supervised progressive aerobic and resistance exercise training intervention on MetS in 100 breast cancer survivors. Main inclusion criteria are histologically-confirmed breast cancer stage I-III, completion of chemotherapy and/or radiation within 6 months prior to initiation of the study, sedentary, and free from musculoskeletal disorders. The primary endpoint is MetS; secondary endpoints include: muscle strength, shoulder function, cardiorespiratory fitness, body composition, bone mineral density, and QOL. Participants randomized to the Exercise group participate in 3 supervised weekly exercise sessions for 16 weeks. Participants randomized to the Control group are offered the same intervention after the 16-week period of observation.
This is the one of few RCTs examining the effects of exercise on MetS in breast cancer survivors. Results will contribute a better understanding of metabolic disease-related effects of resistance and aerobic exercise training and inform intervention programs that will optimally improve physiological and psychosocial health during cancer survivorship, and that are ultimately aimed at improving prognosis.
NCT01140282; Registration: June 10, 2010