Cancer Control Research
5R21CA092468-02
Demark-Wahnefried, Wendy
STRENGTH--SURVIVOR TRAINING FOR ENHANCING TOTAL HEALTH
Abstract
DESCRIPTION (provided by applicant): Weight gain is a common side effect that
accompanies adjuvant chemotherapy for breast cancer. While the phenomenon of
weight gain is consistent, the magnitude is greater among patients who receive
multi-agent, high dose regimens and among those who are younger (25 percent of
premenopausal patients gain over 11 kg during treatment). Patients report
weight gain as "distressing" There also is evidence that weight gain adversely
affects disease-free survival, and predisposes women to cardiovascular disease
and diabetes. Chemotherapy-induced weight gain also is distinct - patients lose
muscle as they gain adipose tissue, thus calling for interventions that promote
exercise. In a preliminary study, we found that losses in muscle and gains in
fat can be prevented if patients participate in a clinic-based program that
promotes specific exercises and a low fat, high vegetable and fruit diet during
the time they receive treatment. While these data are encouraging, few patients
participated due to barriers of travel. Since many cancer patients travel long
distances to receive care, the purpose of this R21 application is to ascertain
whether home-based exercise interventions are feasible using the framework of
the cooperative group (Cooperative Community Oncology Program (CCOP)) and show
promise for further testing in a larger group setting, such as the Cancer and
Leukemia Group B (CALGB).
We have adapted our program that was based in a state-of-the-art fitness
facility to portable gym equipment, and have developed accompanying materials
(i.e., videotapes and manuals), as well as a program of telephone counseling.
We also have obtained the support of the Wake Forest Research Base CCOP to help
us ascertain whether a home-based exercise program bears promise and is
feasible to implement and test using the infrastructure of the cooperative
group. We propose a study that will measure the effects of an exercise alone or
exercise plus diet intervention on preventing weight gain and adverse changes
in body composition, reducing depression, improving quality of life and
influencing biomarkers associated with breast cancer and other co-morbid
conditions (i.e., insulin, insulin-like growth factor-i, sex hormone binding
globulin and lipoprotein profiles). We propose a pilot study where these
endpoints will be assessed at baseline and 6 months post-diagnosis in 90
premenopausal early stage breast cancer patients who will receive adjuvant
chemotherapy and are block randomized into 1 of 3 study arms (attention
control, exercise alone or exercise plus diet). If data show promise, further
and larger study will be pursued - study which will be focused on testing an
optimal intervention and powered on known effect sizes.
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