A Phase II Randomized Study to Assess the Feasibility of Distance Medicine Based Exercise and Dietary Approaches to Prevent Body Composition Change Occurring During Adjuvant Chemotherapy for Early Stage Breast Cancer
- Compare the efficacy of exercise alone or combined with a modified diet as home-based
interventions to prevent increases in body fat during adjuvant chemotherapy in women
with stage I, II, or IIIA breast cancer.
- Compare the efficacy of these regimens, in terms of reducing gains in adipose tissue,
reducing losses in absolute amounts of lean body tissue, reducing gains in weight,
influencing levels of biomarkers associated with the risk of breast cancer and/or other
comorbid conditions, improving self-efficacy for exercise behaviors, reducing
depression, and improving quality of life in these patients.
- Compare the adherence rates to these regimens in these patients.
- Determine the associations between study condition and adherence and change in
endpoints in patients treated with these regimens.
- Determine the feasibility of conducting home-based exercise and diet studies using the
infrastructure of the cooperative group.
OUTLINE: This is a pilot, randomized, multicenter study. Patients are stratified according
to body mass index (no more than 25 kg/m^2 vs more than 25 kg/m^2), race (white vs
non-white), and prior exercise history (vigorous exercise of at least 30 minutes, 3 times a
week prior to diagnosis) (yes vs no). Patients are randomized to 1 of 3 treatment arms.
- Arm I (calcium-rich diet): Patients receive materials and counseling to promote a diet
that contains ample amounts of calcium (1,200-2,500 mg/day).
- Arm II (calcium-rich diet and exercise): Patients receive materials and counseling as
in arm I and instruction and materials to promote strength training and endurance
- Arm III (calcium-rich, high fruit and vegetable, low-fat diet and exercise): Patients
receive materials and counseling as in arm II and materials and counseling to consume
at least 5 servings of vegetables and fruit per day and limit fat intake to less than
20% of total calories.
In all arms, patients continue regimens for 6 months.
Measurements of body composition, weight, waist circumference, serum levels of insulin,
insulin-like growth factor, sex hormone-binding globulin, and total cholesterol are obtained
at baseline and 6 months.
Quality of life, depression, diet composition, and physical activity are assessed at
baseline and at 3 and 6 months.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this
study within 16 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Distance Medicine Based Diet Exercise Program Within the Cooperative Group Setting
Assess estimates of effect sizes and to ascertain potential feasibility of implementing a distance-medicine based diet-exercise program within the cooperative group setting.
Edward G. Shaw, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Southeastern Medical Oncology Center||Goldsboro, North Carolina 27534|
|Cancer Centers of the Carolinas - Eastside||Greenville, South Carolina 29601|