Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Breast Neoplasms

Depression

Depressive Disorder

Body Weight

Body Weight Changes

Breast Diseases

Skin Diseases

Behavioral Symptoms

All Drugs and Chemicals

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Hormones

Calcium-Rich Diet (dietary counseling + materials promoting an intake of 1,200 - 2,500 mg/day).

Exercise + Calcium Rich Diet (dietary counseling + materials promoting strength training and aerobic activity + a calcium intake of 1,200 - 2,500 mg/day).

Dietary counseling + materials promoting strength training and aerobic activity + a diet that has \< 20% of energy coming from fat and intakes of fruits and vegetables of \> 5 servings/day + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.

1,200 - 2,500 mg/day. 6 month intervention

Calcium-Rich Diet

Dietary counseling + material promoting strength training an aerobic activity + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.

Arm 2: Exercise + Calcium-Rich Diet

1,200 - 2,500 Calcium intake per day. 6 month intervention period.

Exercise + Fruit & Vegetable, Low Fat + Calcium Diet

Edward G. Shaw, MD

Wendy Demark-Wahnefried, PhD

Roger T. Anderson, PhD

RATIONALE: A home-based exercise and/or diet program may improve the quality of life of breast cancer patients by preventing an increase in body fat and weight and a loss of lean body tissue.

PURPOSE: This randomized phase II trial is studying the effectiveness of three home-based diet and/or exercise programs in preventing weight gain and loss of muscle tissue in women who are receiving chemotherapy for stage I, stage II, or stage IIIA breast cancer.

OBJECTIVES:

* 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 exercises.
* 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.

Survival TRaining for ENhancing Total Health (STRENGTH)

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

Assess estimates of effect sizes and to ascertain potential feasibility of implementing a distance-medicine based diet-exercise program within the cooperative group setting.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Survival TRaining for ENhancing Total Health (STRENGTH)	NCT00068458	Breast Cancer Depression Weight Changes	Calcium-Rich Di... Arm 2: Exercise... Exercise + Frui...	18 Years -	Duke University
Survival TRaining for ENhancing Total Health (STRENGTH)	NCT00068458	Breast Cancer Depression Weight Changes	Calcium-Rich Di... Arm 2: Exercise... Exercise + Frui...	18 Years -	Duke University

Spots Global Cancer Trial Database for exercise + fruit & vegetable, low fat + calcium diet