Survival TRaining for ENhancing Total Health (STRENGTH)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer, Depression, Weight Changes

Intervention / Treatment
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* Dietary Supplement: Calcium-Rich Diet
* Other: Arm 2: Exercise + Calcium-Rich Diet
* Other: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Stage I, II, or IIIA Scheduled to receive adjuvant chemotherapy OR received 1 prior course of chemotherapy Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal Status Premenopausal, defined as at least 1 of the following: Less than 4 months since last menstrual period at diagnosis Follicle-stimulating hormone level in the premenopausal range Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal No calcium-based kidney stones Cardiovascular No angina within the past 6 months No myocardial infarction within the past 6 months No abnormal MUGA and/or stress test Other Not pregnant or nursing Access to a telephone Able to read and speak English No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer No history of hyperthyroidism or hypothyroidism No paralysis No osteoarthritis with uncontrolled joint pain that would preclude exercise No diverticulitis No serious medical or psychiatric illness that would preclude giving informed consent or completing study therapy or quality of life questionnaires No medical condition that would interfere with body composition assessment No medical condition for which unsupervised exercise is contraindicated No medical condition for which a high vegetable and fruit diet or a calcium-rich diet is contraindicated PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery No prior bilateral oophorectomy No prior amputation No concurrent transverse rectus abdominis myocutaneous surgery No concurrent surgery Other No concurrent blood-thinners (e.g., coumadin or warfarin)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: calcium diet<br>Calcium-Rich Diet (dietary counseling + materials promoting an intake of 1,200 - 2,500 mg/day). | Dietary Supplement: Calcium-Rich Diet<br>* 1,200 - 2,500 mg/day. 6 month intervention<br>* Other names: Calcium;|
| Active Comparator: Arm 2: Exercise + Calcium-Rich Diet<br>Exercise + Calcium Rich Diet (dietary counseling + materials promoting strength training and aerobic activity + a calcium intake of 1,200 - 2,500 mg/day). | Other: Arm 2: Exercise + Calcium-Rich Diet<br>* Dietary counseling + material promoting strength training an aerobic activity + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.<br>* Other names: Calcium;|
| Active Comparator: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet<br>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. | Other: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet<br>* 1,200 - 2,500 Calcium intake per day. 6 month intervention period.<br>* Other names: Calcium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight changes, depression, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer