Status:
COMPLETED
Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT00463489
Start Date
August 1 2007
End Date
June 1 2018
Last Update
September 26 2018
Active Locations (21)
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1
Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, United States, 02215
4
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109