Breast Cancer Clinical Trial
Official title:
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer
This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant endocrine therapy (AET).
This is a single-arm pilot study (n=20) designed to evaluate whether a six-month intermittent fasting (IF) intervention, defined as a daily recurring fourteen-hour nightly fasting period, is feasible to adhere to and feasible to determine health outcomes in breast cancer patients with a body mass index (BMI) of ≥25 and who are scheduled to start adjuvant endocrine therapy (AET) after definitive therapy. Subjects with hormone receptor positive, HER2-negative breast cancer will be enrolled into this study. Data on study feasibility, quality of life (QOL) and anthropometric measurements, and biomarkers will be collected and analyzed. After the study is completed, the investigators may also perform a post-hoc analysis on subjects who received adjuvant chemotherapy in combination with AET vs. AET alone. ;
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