Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
N/A
N/A
Female
Breast Cancer
Trial Information
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.
Inclusion Criteria:
- Post-menopausal woman with a diagnosis of invasive breast cancer (T1-3,pN0-2,M0) for
which definitive surgery was performed during the previous 36 months.
- On adjuvant hormonal therapy with letrozole at time of randomization (either as
initial adjuvant hormonal therapy or after a switch from tamoxifen or other hormonal
therapy).
- BMI ≥ 24 kg/m2.
- Medical, surgical or radiation oncologist agrees to subject participation in a diet
and physical activity program.
Exclusion Criteria:
- Life expectancy less than five years.
- Self-reported inability to walk at least 2 blocks (at any pace).
- Insulin requiring diabetes (telephone directed diet and physical activity changes
would be difficult in this population without close coordination with the treating
physician). Non-insulin requiring diabetics are eligible for the study.
- Serious digestive and/or absorptive problems, including inflammatory bowel disease
and chronic diarrhea that preclude adherence to the study diet.
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that
preclude moderate physical activity. Moderate arthritis that does not preclude
physical activity is not a reason for ineligibility.
- Psychiatric disorders or conditions that, in the opinion of the investigator, would
preclude participation in the study intervention (e.g. untreated major depression or
psychosis, substance abuse, severe personality disorder).
- Patients on aromatase inhibitors other than letrozole at study entry.
- Known recurrence of breast cancer (local, regional or distant) at any time prior to
study entry.
- History of other malignancies except: adequately treated non-melanoma skin cancer,
curatively treated in situ carcinoma of the cervix, or other solid tumours curatively
treated with no evidence of disease for ≥ 5 years. Prior in situ cancer of the breast
is not a reason for exclusion.
- Patients not fluent in either English or French (spoken and written).
- Patient unwilling or unable to provide informed consent.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Disease-free survival
Outcome Time Frame:
8 years
Safety Issue:
No
Principal Investigator
Pamela J Goodwin, MD, MSc
Investigator Role:
Principal Investigator
Investigator Affiliation:
UHN-Mount Sinai Hospital, Toronto, ON
Authority:
Canada: Health Canada
Study ID:
OCOG-2007-LISA
NCT ID:
NCT00463489
Start Date:
August 2007
Completion Date:
May 2018
Related Keywords:
- Breast Cancer
- lifestyle intervention
- breast
- cancer
- adjuvant
- letrozole
- weight loss
- BMI
- post-menopausal
- estrogen receptor positive
- progesterone receptor positive
- Breast Neoplasms
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 |
