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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343434
• Other study ID #: CCCWFU-98904
• Secondary ID: CDR0000481274
• Status: Completed
• Phase: N/A
• First received: June 22, 2006
• Last updated: January 17, 2017
• Start date: January 2005

Study information

• Verified date: June 2013
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity

Intervention

Behavioral:
• behavioral dietary intervention

• exercise intervention

Dietary Supplement:
• soy isoflavones

• soy protein isolate

Other:
• counseling intervention

• educational intervention

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,