Status:
COMPLETED
Soy-Based Meal Replacement in Helping Women With Stage I, Stage II, or Stage III Breast Cancer in Complete Remission Lose Weight
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Obesity
Eligibility:
All Genders
21-120 years
Phase:
NA
Brief 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 m...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00343434
Start Date
January 1 2005
Last Update
January 19 2017
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096