Breast Cancer Clinical Trial
Official title:
Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors
Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese.
The American Cancer Society has called for weight loss treatment to be standard of care for
overweight women with breast cancer. During therapy women with breast cancer often gain
weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have
their cancer come back. The reason why overweight breast cancer survivors are more likely to
re-occur has not been well studied, but changes in how insulin works may contribute.
Overweight survivors are also at risk for the other chronic diseases associated with
obesity. Fortunately, weight losses of as little as 5-7% of baseline body weight can improve
risk of chronic disease. An effective behaviorally-based, lifestyle intervention delivered
via the internet has been developed at the University of Vermont. This successful
intervention has not been tested among breast cancer survivors. Given that women tend to
lose muscle mass during cancer therapy the addition of a resistance training component to
the weight loss intervention may be important. Therefore the overall goal of this project is
to pilot test a proven distantly- delivered behavioral weight loss intervention among
overweight breast cancer survivors and to evaluate whether a resistance program results in
improvements in lean body mass, while studying how both interventions change insulin
sensitivity.
Specifically, this project is a randomized, controlled clinical trial designed to test the
effectiveness and acceptability of a 6-month behavioral weight loss intervention with and
without resistance training. Participants will be randomized to one of two groups: 1)
behavioral weight control treatment via the Internet; or 2) behavioral weight control
treatment via the Internet plus a resistance training program. Women eligible to participate
include overweight breast cancer survivors who are age 50 or older and 6-36 months past
receiving chemotherapy. Assessments will be conducted at baseline and six months and will
include measures of body weight, muscle mass, adherence to treatment, and insulin
sensitivity.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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