Clinical trial NCT00463489: Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
Official title: Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: lifestyle intervention
breast
cancer
adjuvant
letrozole
weight loss
BMI
post-menopausal
estrogen receptor positive
progesterone receptor positive
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2007-04-20
Enrollment: 338
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival
timeFrame: 8 years
Secondary outcomes:
measure: Overall survival
timeFrame: 8 years
measure: Distant disease-free survival
timeFrame: 8 years
measure: Weight at 6, 12, 24, 36, 48 and 60 months compared to baseline
timeFrame: 5 years
measure: Health-related quality of life at 6, 12, 24, 36, 48 and 60 months compared to baseline
timeFrame: 5 years
measure: Other medical endpoints such as diabetes, cardiovascular disease, arthritis, fasting biomarkers at 12 months compared to baseline (for women participating in a biospecimen substudy)
timeFrame: 8 years
measure: Compliance with study procedures.
timeFrame: 8 years
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center
state: California
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Kelowna
country: Canada
facility: Bcca - Csi
state: British Columbia
city: Cambridge
country: Canada
facility: Cambridge Memorial Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Centere
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Regional Cancer Centre
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Algoma District Cancer Program
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Hospital
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Trillium Healthcare Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Greenfield Park
country: Canada
facility: Hopital Charles LeMoyne
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Hotel Dieu de Montreal
state: Quebec
Study officials:
affiliation: UHN-Mount Sinai Hospital, Toronto, ON
name: Pamela J Goodwin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.