Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

Breast Cancer Clinical Trial

— LISA  

Official title:

Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463489
• Other study ID #: OCOG-2007-LISA
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: June 2018

Study information

• Verified date: September 2018
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Lifestyle intervention
Women randomized to the lifestyle intervention arm will receive an intervention program that consists of individual weight loss, diet and physical activity goals, incorporated into a 2 year standardized, structured telephone and mail-based intervention. In addition to diet and physical activity, the intervention will address behavioural and motivational issues relating to weight management including maintaining motivation, overcoming obstacles to success, relapse prevention, emotional distress, stress and time management.
• Mail-based
Participants will receive a standardized mail-based intervention focussing on healthy living. This will include mailings at study entry as well as a two year subscription to health magazine.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Goodwin PJ, Segal RJ, Vallis M, Ligibel JA, Pond GR, Robidoux A, Blackburn GL, Findlay B, Gralow JR, Mukherjee S, Levine M, Pritchard KI. Randomized trial of a telephone-based weight loss intervention in postmenopausal women with breast cancer receiving letrozole: the LISA trial. J Clin Oncol. 2014 Jul 20;32(21):2231-9. doi: 10.1200/JCO.2013.53.1517. Epub 2014 Jun 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		8 years
Secondary	Overall survival		8 years
Secondary	Distant disease-free survival		8 years
Secondary	Weight at 6, 12, 24, 36, 48 and 60 months compared to baseline		5 years
Secondary	Health-related quality of life at 6, 12, 24, 36, 48 and 60 months compared to baseline		5 years
Secondary	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
Secondary	Compliance with study procedures.		8 years