Abstract
TPS11633 Background: The World Cancer Research Fund and the American Cancer Society provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines. Adoption of recommended lifestyle behaviors soon after diagnosis may prevent adverse changes in body composition, breast cancer biomarkers, and may improve adherence to treatment thereby improving breast cancer prognosis. The Lifestyle, Exercise, and Nutrition Early after Diagnosis (LEANER) study is testing the impact of a healthy lifestyle intervention on chemotherapy completion and endocrine therapy adherence. Secondary endpoints include changes in inflammatory and metabolic biomarkers, body composition, and patient reported outcomes. Methods: Eligible participants are women with stage I-III breast cancer undergoing chemotherapy. 250 participants are being recruited and randomized 1:1 to a yearlong, 16 session, healthy diet and exercise counseling intervention or usual care group. The intervention is delivered in person and/or via telephone by registered dietitians with training in exercise science. Materials include workbooks, videos, cookbooks, fit bits, and home-based exercise equipment. Intervention is focused on graduated goal setting to meet the recommended diet and exercise guidelines for cancer survivors. The primary endpoint, chemotherapy completion rate, is gathered from the Electronic Medical Record and the average Relative Dose Intensity for the originally planned regimen is calculated based on standard formulas. Assessments are completed at baseline, post chemotherapy, 1- and 2- year time points (to assess adherence to endocrine therapy). Body composition is measured using dual energy X-ray absorptiometry, blood samples and patient reported outcomes are collected. At time of submission, 39 women have been randomized. Discussion: If successful, this study has the potential to make healthy lifestyle interventions initiated shortly after diagnosis a standard component of breast cancer treatment. Clinical trial information: NCT03314688.
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