NCT06106477

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Intermittent 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).

Timeline

• Start date: 2024-07-19
• Primary completion: 2026-07-15
• Completion: 2026-07-15
• First posted: 2023-10-30
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States