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

Wake Forest University Health Sciences25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

SUPPORTIVE_CARE

Enrollment

Conditions

Breast Cancer Obesity

Interventions

behavioral dietary interventionBEHAVIORAL

exercise interventionBEHAVIORAL

soy isoflavonesDIETARY_SUPPLEMENT

soy protein isolateDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 21 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Data from ClinicalTrials.gov

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