Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00463489

Run by

Ontario Clinical Oncology Group (OCOG)

People needed

338

Starts

2007-08-01

Expected to finish

2018-06-01

Last updated by the study team

2018-09-26

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center — Torrance, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Centre — Boston, Massachusetts, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Bcca - Csi — Kelowna, British Columbia, Canada
• Cambridge Memorial Hospital — Cambridge, Ontario, Canada
• Juravinski Cancer Centre — Hamilton, Ontario, Canada
• Grand River Regional Cancer Centere — Kitchener, Ontario, Canada
• London Regional Cancer Centre — London, Ontario, Canada
• Ottawa Hospital Regional Cancer Centre — Ottawa, Ontario, Canada
• Algoma District Cancer Program — Sault Ste. Marie, Ontario, Canada
• Scarborough Hospital — Scarborough Village, Ontario, Canada
• Niagara Health System — St. Catharines, Ontario, Canada
• Thunder Bay Regional Health Science Centre — Thunder Bay, Ontario, Canada
• Sunnybrook Odette Cancer Centre — Toronto, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada
• Trillium Healthcare Centre — Toronto, Ontario, Canada
• Windsor Regional Cancer Centre — Windsor, Ontario, Canada
• Hopital Charles LeMoyne — Greenfield Park, Quebec, Canada
• CHUM - Hotel Dieu de Montreal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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