Soy-Based Meal Replacement in Helping Women With Stage I, Stage II, or Stage III Breast Cancer in Complete Remission Lose Weight
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.
Behavioral: behavioral dietary intervention
Behavioral: exercise intervention
Dietary Supplement: soy isoflavones
Dietary Supplement: soy protein isolate
Other: counseling intervention
Other: educational intervention
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||Use of a Soy-Based Meal Replacement Weight Loss Intervention for Survivors of ER/PR Negative Breast Cancer|
|Study Start Date:||January 2005|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343434
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||Mara Vitolins, DrPH, RD||Comprehensive Cancer Center of Wake Forest University|