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

21 Years
Not Enrolling
Breast Cancer, Obesity

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Trial Information

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


- 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.

Inclusion Criteria


- 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


- 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

- No definite plans to move out of the area during the study period


- See Disease Characteristics

- No concurrent medications for weight loss

- No concurrent treatment for ER/PR-negative disease

Type of Study:


Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Mara Vitolins, DrPH, RD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

January 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • Obesity
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • obesity
  • Breast Neoplasms
  • Obesity



Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096