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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.

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.

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.

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.

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.

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 (tara.sanft@yale.edu; melinda.irwin@yale.edu or 203-764-8426).