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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA081851 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: calcium diet | Active Comparator | Calcium-Rich Diet (dietary counseling + materials promoting an intake of 1,200 - 2,500 mg/day). |
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| Arm 2: Exercise + Calcium-Rich Diet | Active Comparator | Exercise + Calcium Rich Diet (dietary counseling + materials promoting strength training and aerobic activity + a calcium intake of 1,200 - 2,500 mg/day). |
|
| Exercise + Fruit & Vegetable, Low Fat + Calcium Diet | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium-Rich Diet | Dietary Supplement | 1,200 - 2,500 mg/day. 6 month intervention |
|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Scheduled to receive adjuvant chemotherapy OR received 1 prior course of chemotherapy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal Status
Premenopausal, defined as at least 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Edward G. Shaw, MD | Wake Forest University Health Sciences | Study Chair |
| Wendy Demark-Wahnefried, PhD | Duke Cancer Institute | Principal Investigator |
| Roger T. Anderson, PhD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States | ||
| Southeastern Medical Oncology Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18501061 | Result | Demark-Wahnefried W, Case LD, Blackwell K, Marcom PK, Kraus W, Aziz N, Snyder DC, Giguere JK, Shaw E. Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. Clin Breast Cancer. 2008 Feb;8(1):70-9. doi: 10.3816/CBC.2008.n.005. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D015444 | Exercise |
| D005638 | Fruit |
| D014675 | Vegetables |
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| Arm 2: Exercise + Calcium-Rich Diet | Other | Dietary counseling + material promoting strength training an aerobic activity + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention. |
|
|
| Exercise + Fruit & Vegetable, Low Fat + Calcium Diet | Other | 1,200 - 2,500 Calcium intake per day. 6 month intervention period. |
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| Goldsboro |
| North Carolina |
| 27534 |
| United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1030 | United States |
| Cancer Centers of the Carolinas - Eastside | Greenville | South Carolina | 29615 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |