Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00463489
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

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 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.

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 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.

Study Timeline

• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Study Start: 2007-08
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 338

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease-free survival	8 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	8 years
Distant disease-free survival	8 years
Weight at 6, 12, 24, 36, 48 and 60 months compared to baseline	5 years
Health-related quality of life at 6, 12, 24, 36, 48 and 60 months compared to baseline	5 years
Other medical endpoints such as diabetes, cardiovascular disease, arthritis, fasting biomarkers at 12 months compared to baseline (for women participating in a biospecimen substudy)	8 years
Compliance with study procedures.	8 years

Trial Locations

Locations (21)

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

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