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 (WFU)

Status: Completed

Conditions: Breast Cancer; Obesity

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00343434

CCCWFU-98904

CDR0000481274 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 21 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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