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Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer


Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

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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