Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
Categories (click each to see list of all clinical trials associated with that category): Breast
Current Status: Open to accrual
Phase: III
Principal Investigator: Wahl, Andrew
Contact Information:
Amy Filler-Katz, RN, BSN, CCRP
402-552-2790
afillerkatz@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02750826#eligibility
Summary
Primary objective To compare the effect of a supervised weight loss intervention plus health education materials versus health education materials alone upon invasive disease free survival (IDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI ≥30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer.
Secondary objectives
To determine the relationship between changes in weight and IDFS, and to explore interaction between the level of clinical benefit from weight loss and the intervention.
To evaluate the effect of a supervised weight loss intervention upon:
Overall survival
Distant disease free survival
Weight
Body composition (as measured by waist and hip circumference)
Insulin Resistance Syndrome associated conditions - diabetes, hospitalization for CV disease
To determine the impact of a supervised weight loss intervention on IDFS within subgroups of women with 1) hormone receptor positive breast cancer and 2) hormone receptor negative breast cancer.
To determine the impact of a supervised weight loss intervention on IDFS within subgroups of 1) premenopausal women and 2) post-menopausal women.