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
- 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.
Primary Purpose: Supportive Care
Mara Vitolins, DrPH, RD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|