Physical Activity in Helping Lose Weight in Breast Cancer Survivors and High Risk Women
This trial studies how well physical activity works in helping lose weight in breast cancer survivors and women who are at high risk for development of breast cancer. Modest calorie restriction with a graduated physical activity may help people to lose weight.
Inclusion Criteria
- COHORT A2: Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or surgery at least 3 months prior to study entry; may continue to take endocrine therapy and/or maintenance trastuzumab
- COHORT B: No prior diagnosis of breast cancer but at high risk for development of breast cancer and participating in HSC 4601
- Body mass index (BMI) > 30 kg/m^2; women with a BMI > 45 kg/m^2 must be age < 60 and ability to perform physical activity must be confirmed
- 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
- Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data accessed by study personnel; access to a personal computer * In general Android, Apple products and Windows 10 phones or any phone with Bluetooth Smart, will run Garmin Connect; (iPhone 5,5s,6,6s,7,7+; most recent Motorola, Samsung, Google Nexus, Sony, and Nokia products)
- Live in the greater Kansas City metropolitan area
- Willing and able to perform moderate intensity exercise at least 5 days per week for 6 months; this consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week; must be willing to perform unsupervised home exercise for the entire 6 months
- Willing to participate in a weekly behavioral modification group phone call for first 3 months and every 2 weeks for the second 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 6 months and track food intake and exercise
- A complete blood count (CBC) and chemistry profile (Cohort A2), must have been performed after completion of any breast cancer surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver and renal function as well as a hemoglobin of 10 or higher and/or performed within a year of study entry
Exclusion Criteria
- Use of metformin, insulin, steroids or prescription weight loss or anti-psychotic drugs within the prior 3 weeks
- Individuals with prior gastric bypass surgery or procedure that would impair absorption of nutrients
- 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 NCT03270111.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To validate the 3 month findings of the first study for moderate to vigorous physical activity (MVI PA), visceral adipose tissue (VAT) change and modulation of other risk biomarkers including plateau level of oxygen consumption during maximal physical activity (VO2peak), cytokines (especially TNF-alpha), adipokines (adiponectin and leptin) as well as patient reported outcomes.
II. To determine if the volume of MVI PA achieved during the initial 3 months can be sustained or augmented during the subsequent 3 months of the intervention.
III. To explore the effect of varying amounts of MVI PA on additional risk biomarkers including mammographic fibroglandular volume (Volpara), benign breast tissue targeted micro ribonucleic acid (miRNA), lysyl oxidase, blood sirtuins (longevity) and isoprostanes (oxidative stress).
OUTLINE:
Participants attend a group orientation session and then start a 6-month weight loss program that consists of portion controlled meals and a prescribed level of physical activity. Participants participate in supervised exercise sessions 2 times per week at a local Young Men's Christian Association (YMCA), and weekly phone group sessions in the first 3 months. Participants then move to unsupervised exercise and fewer group phone sessions in the second and third months.
After completion of study, participants are followed up at 2 weeks.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorCarol J. Fabian
- Primary IDSTUDY00141301
- Secondary IDsNCI-2018-00342
- ClinicalTrials.gov IDNCT03270111