Soy-Based Meal Replacement in Helping Women With Stage I, Stage II, or Stage III Breast Cancer in Complete Remission Lose Weight

Study Overview
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Brief Summary
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RATIONALE: A diet using a soy-based meal replacement may help survivors of breast cancer lose weight and improve their quality of life. PURPOSE: This clinical trial is studying how well a soy-based meal replacement works in helping women with stage I, stage II, or stage III breast cancer in complete remission lose weight.

Detailed Description
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OBJECTIVES: Determine the ability to recruit survivors of estrogen receptor/progesterone receptor (ER/PR)-negative stage I-III breast cancer to participate in a 3-month, soy-based, meal-replacement (Almased®) weight loss intervention. Assess the patient's ability to adhere to this intervention protocol. Measure changes in anthropometrics (body weight, bioelectrical impedance, waist circumference) and biomarkers (serum levels of glucose, insulin, highly specific C-reactive protein, insulin-like growth factor, insulin-like growth factor binding protein-3, lipids). Measure changes in health-related quality of life. OUTLINE: This is a prospective, longitudinal, pilot study. Patients undergo goal-oriented, cognitive-behavioral therapy comprising group counseling weekly for 3 weeks and individual counseling once a month. Weight loss interventions include behavioral techniques, dietary modification (using a portion-controlled diet and soy-based meal-replacement [Almased®] once or twice daily), physical activity (≥ 15 minutes per day, 6 days a week), and social support. Weight loss is monitored weekly and patients complete daily logs of dietary intake and physical activity. Therapy continues for 12 weeks. Health-related quality of life is assessed at baseline and then weekly for 12 weeks. Patients undergo blood draws at baseline and at 12 weeks for analysis of C-reactive protein, glucose, insulin, insulin-like growth factor (ILGF), and ILGF-binding protein-3. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Official Title
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Use of a Soy-Based Meal Replacement Weight Loss Intervention for Survivors of ER/PR Negative Breast Cancer

Conditions
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Breast Cancer, Obesity

Intervention / Treatment
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* Behavioral: behavioral dietary intervention
* Behavioral: exercise intervention
* Dietary Supplement: soy isoflavones
* Dietary Supplement: soy protein isolate
* Other: counseling intervention
* Other: educational intervention
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Previously diagnosed stage I-III breast cancer currently in complete remission Completed treatment for breast cancer ≥ 6 months ago Free of disease at last clinic visit Body mass index ≥ 27 Hormone receptor status Estrogen receptor (ER)/progesterone receptor (PR) negative PATIENT CHARACTERISTICS: Female Menopausal status not specified No history of soy allergies No uncontrolled blood pressure No uncontrolled hyperthyroidism or hypothyroidism Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No diabetes mellitus (type 1 or 2) No medical, psychiatric, or behavioral factors that would preclude study participation No definite plans to move out of the area during the study period PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent medications for weight loss No concurrent treatment for ER/PR-negative disease

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

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: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: behavioral dietary intervention|nan|
|Behavioral: exercise intervention|nan|
|Dietary Supplement: soy isoflavones|nan|
|Dietary Supplement: soy protein isolate|nan|
|Other: counseling intervention|nan|
|Other: educational intervention|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, obesity