Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:3/1/2019
Start Date:November 2013
End Date:January 2021

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Trial Summary
Trial Overview
Inclusion Criteria

Lifestyle, Exercise and Nutrition (LEAN) Study 2

The specific aims of this study are to determine the efficacy and cost-effectiveness of a
weight loss program compared with usual care (control) treatment on 6-month changes in body
weight, body fat, serum hormones, and breast tissue markers associated with prognosis in
breast cancer survivors.

We will conduct a two-armed study comparing a combination of an in-person and telephone
weight loss program compared to usual care/wait list in 100 breast cancer survivors. Women
will be randomized into one of the study arms using a random permuted block design. Research
staff collecting body composition data, as well as reviewing forms and entering data, will be
blinded to the participant's study group.

Inclusion Criteria:

- American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer

- BMI >25 kg/m2

- Completed surgery, chemotherapy and radiation at least 2 months ago

- Physically able to exercise

- Agrees to be randomly assigned to either weight loss or control

- Gives informed consent to participate in all study activities

- Able to come for baseline and 6-month clinic visits

- Mentally competent

Exclusion Criteria:

- Patients with double mastectomy
We found this trial at
1
site
Yale University
New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Melinda L Irwin, PhD, MPH
Phone: 203-785-6392
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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