Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
The primary objective of this trial is to evaluate the effect of the addition of a 2 year,
centrally delivered individualized, telephone-based lifestyle intervention focusing on
weight management to a mailed educational intervention on Disease Free Survival in
post-menopausal women with early stage breast cancer (hormone receptor positive), BMI
≥24-<40 kg/m2, who are receiving standard letrozole adjuvant therapy. The telephone
intervention will involve 19 phone calls, as well as mailings and a participant manual;
women will be asked to lose up to 10% of their weight by reducing their caloric and fat
intake (by 500-1000 kcal/day, 20% calories fat) and increasing their moderate physical
activity (to 150-200 minutes/week). Secondary outcomes include overall survival, distant
disease-free survival, weight change, health-related quality of life (HRQOL), selected
non-cancer medical events and biologic factors (notably insulin). Approximately 2,150 women
will be enrolled; follow-up will continue until target event rates have been met
(anticipated 4-6 years after completion of the intervention). This sample size will provide
80% power (type 1 error 0.05 2-tailed) to detect a hazard ratio (HR) for DFS of 0.74-0.76 in
the weight loss intervention arm.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Disease-free survival
8 years
No
Pamela J Goodwin, MD, MSc
Principal Investigator
UHN-Mount Sinai Hospital, Toronto, ON
Canada: Health Canada
OCOG-2007-LISA
NCT00463489
August 2007
May 2018
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center | Torrance, California 90502 |
Beth Israel Deaconess Medical Centre | Boston, Massachusetts 02215 |