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What is the LEAN study?

Contact Info

Breast Cancer Emergency Center
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LEAN Study Research Team

Melinda L. Irwin, PhD, MPH
Co-Principal Investigator
Yale School of Public Health
55 Church Street - Suite 801
New Haven, CT 06510

Tara Sanft, MD
Co-Principal Investigator
Yale School of Medicine
300 George Street
New Haven, CT 06510

We are inviting women recently diagnosed with breast cancer and beginning chemotherapy to participate in the Lifestyle, Exercise And Nutrition (LEAN) Study. This research study will look at whether an exercise and nutrition program improves chemotherapy and endocrine therapy (Tamoxifen or Aromatase Inhibitor) completion rates and helps manage side effects. Half of the women in the study will be chosen at random to begin the exercise and nutrition program that involves 16 counseling sessions over one year in addition to their usual care. The other half of the women will be chosen at random to continue with their usual care.

The exercise program includes aerobic exercise, such as brisk walking 30 minutes per day, and a strength training program to be completed in your home. The nutrition program goals follow the US Dietary Guidelines focused on reducing sugar and fat in your diet while increasing the amount of fiber, fruits and vegetables that you eat. A Registered Dietitian will counsel you over the first year of the study on how to eat healthfully and exercise safely.

Frequently Asked Questions

Why should YOU participate in the study?
We know that exercise and healthy eating improves health after breast cancer, but this has been studied mostly in women who have finished their treatment. Few studies have examined the effect of healthy eating and exercise during treatment for breast cancer. If we find exercise and healthy eating improves tolerance to chemotherapy and endocrine therapy, then the standard of care for women diagnosed with breast cancer may change to include exercise and nutrition programs as an integral part of active treatment.
What does the study involve?
A total of 250 women will be enrolled in the study. You cannot choose whether you are in the exercise and nutrition program or usual care group; a computer program will randomly (like flipping a coin) select 125 women for each group. The study involves four visits to Yale New Haven Hospital (One at the beginning of the study, one at the end of chemotherapy, one at one-year and one at two-years). All 250 women will complete health and medical history questionnaires. During each of your four visits, we will draw blood from your arm and you will have a body composition and bone density scan. For this scan you will lie still for about 15 minutes on a padded table. The test does not require you to undress. All these tests are performed by trained staff. For privacy purposes, all information collected is labeled with a study ID number and not your name. The 16 exercise and nutrition counseling sessions will be conducted by one of our Registered Dietitians during your chemotherapy sessions or by telephone or at our office at 55 Church St, New Haven, CT. The 16 sessions will take place over one year (weekly for the first month, every other week for months 2 and 3, and monthly for months 4-12). These visits/calls will last approximately 30 minutes.
Are there any costs to participate?
No, all testing and sessions are provided to you at no charge. Also, for any visits to the hospital or our office, we will pay for your parking.
Are you eligible?
You may be eligible to participate in this study if you were diagnosed with breast cancer and are going to have chemotherapy. We will ask you some additional questions to make sure you are eligible for the study.
How will you benefit?
By participating in this study, you will play an important role in finding out how exercise and nutrition may improve tolerance to breast cancer treatment and help manage side effects. You will learn how to eat healthfully and exercise safely. It is only through the generous cooperation of people like yourself that we can learn more about treatment for breast cancer.
Who are we and who is paying for the study?
The Lifestyle, Exercise And Nutrition (LEAN) Study, a Yale School of Medicine study, has been funded by the National Cancer Institute and the Breast Cancer Research Foundation. The principal investigators are Tara Sanft, MD and Melinda Irwin, PhD, MPH.

Human Investigation Committee number: 2000020335