This randomized pilot trial studies how well a weight loss exercise intervention with or without resistance training works in improving lean mass in endometrial cancer survivors. Weight loss reduces adipose tissue and lean mass which can alter physical function. Resistance training can improve muscle mass to a greater extent than aerobic exercise and it has the potential to be beneficial in preserving lean mass and maintaining physical functioning.
Additional locations may be listed on ClinicalTrials.gov for NCT02774759.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of two home-based weight loss interventions for endometrial cancer survivors, one that recommends both resistance training and moderate-intensity aerobic exercise (NEXT Steps- Aerobic exercise and Resistance Training [NS-ART]) and one that advises moderate-intensity aerobic exercise only (NEXT Steps- Aerobic exercise [NS-A]). Feasibility will be indicated by adherence to exercise recommendations, participant retention, and participant satisfaction.
SECONDARY OBJECTIVES:
I. To estimate the magnitude of the effect sizes and variation in the outcome variables for NS-ART versus (vs) NS-A interventions, specifically changes in weight and lean body mass measured by dual-energy x-ray absorptiometry (DXA), as well as metabolic and inflammatory biomarkers (fasting insulin and glucose, c-peptide, glycosylated hemoglobin [HbA1c], serum triglycerides, high-density lipoprotein [HDL], low-density lipoprotein [LDL], total cholesterol, interleukin-6 [IL-6], adiponectin, C-reactive protein [CRP], tumor necrosis factor- alpha [TNF-alpha], and the novel adipokines visfatin and omentin).
II. To estimate the magnitude of the effect sizes and variation in the outcome variables for NS-ART and NS-A combined vs standard care, specifically changes in weight and lean body mass, as well as the metabolic and inflammatory markers.
III. To estimate the magnitude of the effect sizes and variation in the data for NS-ART vs NS-A vs standard care on quality of life (QOL), physical functioning, and safety.
IV. To estimate the magnitude of the effect sizes and variation in the data for NS-ART and NS-A combined vs standard care on quality of life (QOL), physical functioning, and safety.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I (NS-ART): Patients use a portion control plate at least once daily to plan a meal, and receive a personalized workbook and Fitbit. Patients also receive telephone coaching consisting of phone calls twice a month for 15-30 minutes each and text messages 7 times per week. Patients undergo aerobic exercise over 30-60 minutes 5 days a week and resistance exercise over 15-30 minutes 2 times per week. Patients use iPad mini to video chat twice during month 1 and 3 over 30-60 minutes.
GROUP II (NS-A): Patients use a portion control plate, and receive a personalized workbook, Fitbit, phone calls and text messages and undergo aerobic exercise as in Group I.
GROUP III (CONTROL): Patients receive phone calls twice a month for the first 2 months then once monthly for 4 months and also receive self-help materials.
After the completion of study treatment, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorKaren M. Basen-Engquist
