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
Medical College of Wisconsin
Summary
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).
Description
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 bio…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Breast cancer patients ≥ 18 years old who are willing to consent to an approximately 14-hour nighttime fasting period and an approximately 10-hour daytime eating period. 2. Histologically and/or cytologically confirmed diagnosis of estrogen receptor (ER) positive (ER+) and human epidermal growth factor receptor (HER) 2 negative (HER2-) localized breast cancer (stages I-III). 1. Progesterone receptor positive or negative patients are allowed. 2. Hormone receptor positivity is defined as ER positivity in at least 1% cells by immunohistochemistry (IHC). HER 2-negati…
Interventions
- BehavioralIntermittent Fasting
Participants will be asked to adhere to a six-month intermittent fasting intervention, a daily-recurring dietary plan consisting of: * An approximately fourteen-hour nightly fasting period that is followed by * An approximately ten-hour eating period with their last meal of the day occurring between 17:00 (5:00 PM) and 21:00 (9:00 PM).
Location
- Froedtert Hospital & the Medical College of WisconsinMilwaukee, Wisconsin