Clinical trial NCT02963740: Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors
Official title: Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: breast cancer survivor
weight loss program
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 11
Sex: FEMALE
Maximum age (years): 71
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to demonstrate that breast cancer survivors who need to lose weight are able to follow a weight loss program which combines modest calorie restriction with a graduated activity program..

Detailed description: Feasibility will be assessed by 1) the number of women that complete the 3--month program; 2) the number of women that can achieve the targeted amount of physical activity per week by the end of the program; and 3) the median amount of physical activity achieved group by all subjects that complete the program.

Eligibility criteria: Inclusion Criteria:

* Women \< age 71 in good general health.
* Prior diagnosis of breast cancer.
* At least 3 months from 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/m2.
* 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.
* 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 and track food intake and exercise.

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.

Primary outcomes:
measure: Adherence to supervised exercise sessions
timeFrame: Week 12
Secondary outcomes:
measure: Percent participants meeting physical activity goal
timeFrame: Week 9 to Week 12
measure: Compliance with group telephone sessions
timeFrame: Week 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fabian CJ, Klemp JR, Marchello NJ, Vidoni ED, Sullivan DK, Nydegger JL, Phillips TA, Kreutzjans AL, Hendry B, Befort CA, Nye L, Powers KR, Hursting SD, Giles ED, Hamilton-Reeves JM, Li B, Kimler BF. Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors. Cancers (Basel). 2021 Sep 28;13(19):4871. doi: 10.3390/cancers13194871.