Weight Loss Intervention in Improving Outcomes in Patients with Breast Cancer
This pilot clinical trial studies how well a weight loss intervention works in improving outcomes in patients with breast cancer. Participating in a standard weight loss program consisting of a reduced calorie diet, moderate exercise, and weekly group meetings may help improve the health in patients with breast cancer.
Inclusion Criteria
- Women in good general health
- Diagnosis of breast cancer
- At least 3 months after completion of any cytotoxic chemotherapy or radiation or surgery; may continue to take endocrine therapy and/or maintenance trastuzumab
- Body mass index (BMI) 30-45 kg/m^2
- By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface
- Access to a smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data from these apps viewed by study personnel
- Live in the greater Kansas City metropolitan area
- Willing and able to perform moderate intensity exercise at least 5 days per week for 3 months; this consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week for 8 weeks, then 1 day per week for 4 weeks; must also be willing to perform unsupervised home exercise for the entire 3 months
- Willing to participate in a weekly behavioral modification group phone call for 3 months
- Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal replacements plus 35 servings of fruits and vegetables/week for 3 months and track food intake and exercise
- A complete blood count (CBC) and chemistry profile, must have been performed after completion of any breast cancer surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver and renal function and a hemoglobin of 10 or higher
Exclusion Criteria
- Use of metformin, insulin, steroids or weight loss or anti-psychotic drugs within the prior 3 weeks
- Individuals with prior bariatric surgery procedures
- Need for chronic immunosuppressive drugs
- Participation within the past 6 months on a structured weight loss program such as Weight Watchers
- Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week
- Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event
- Currently receiving investigational agents in a clinical trial
Additional locations may be listed on ClinicalTrials.gov for NCT02963740.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OJECIVES:
I. To determine the proportion of potentially eligible obese, sedentary breast cancer survivors referred by their cancer care providers who agree to be screened for the study, are ultimately eligible, and begin the 3 month diet and exercise intervention.
II. To determine minutes of purposeful moderate intensity exercise, minutes total physical activity, and calories from total physical activity (PA) or active energy expenditure (AEE)/week that 80% of breast cancer survivors are able to achieve at 3 months (after a 2 month supervised ramp up and one month predominately home based exercise program).
III. To explore the effect of varying amounts of purposeful exercise, total physical activity and total calorie expenditure from physical activity achieved on peak oxygen consumption (VO2peak), adipocytokines (e.g. adiponectin/leptin ratio), blood inflammatory biomarkers, body composition (DXA), patient reported cognitive function and other quality of life indices as well as novel biomarkers such as targeted oncogenic micro ribonucleic acid (miRNA).
OUTLINE:
Participants undergo supervised exercise sessions at the YMCA over 20-60 minutes twice weekly at weeks 1-8 and over 60 minutes once weekly at weeks 9-12. Participants wear a Garmin SmartWatch activity tracker continuously for 12 weeks and an Actigraph accelerometer at week 1 and 12. Participants also join a group behavioral phone session over 1 hour once a week for 12 weeks. Patients are encouraged to follow a reduced calorie diet with portion controlled meals, log all food and beverages consumed using the MyFitnessPal smartphone application, and exercise at home over 60-180 minutes per week for 12 weeks.
After completion of the study, patients are followed up at 2 weeks.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorCarol J. Fabian
- Primary IDSTUDY00004575
- Secondary IDsNCI-2016-01979
- ClinicalTrials.gov IDNCT02963740