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RECRUITING
NCT07622901
NA

Fasting InTervention for Endometrial Cancer

Sponsor: University of Miami

View on ClinicalTrials.gov

Summary

The goal of this study is to find out if it is safe for women with endometrial cancer who are going to have surgery to fast (not eat) overnight. Studies have shown that women with endometrial cancer often have problems with metabolism, like high blood sugar. These problems can cause inflammation and may help cancer grow or make treatment less effective. Early research shows that fasting overnight might help improve these problems.

Official title: Fasting InTervention for Endometrial Cancer (FIT-ENDO)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-02-27

Completion Date

2028-02-28

Last Updated

2026-07-14

Healthy Volunteers

No

Interventions

BEHAVIORAL

Prolonged Overnight Fasting (POF)

Participants will be asked to not consume any calorie-containing food/drinks after 8pm and to fast at least 12 hours nightly, increasing to 14 hours gradually over the course of a week. Participants will be asked to maintain the prolonged overnight fasting (POF) for the duration of the intervention, with modifications as needed in the immediate postsurgery phase. Participants will be asked to record the fasting times (morning and evening) either on a paper journal that will be returned to research staff by mail, email, or text message, or by completing an eJournal through My Wellness Research Patients will enroll and begin the intervention 28 +/- 14 days prior to their scheduled surgery (hysterectomy) and continue for 6 weeks postsurgery.

PROCEDURE

Blood Specimen Collection

Blood specimens will be collected from participants at baseline (T0), the day of surgery (T1), and at six weeks post-surgery (T2).

OTHER

Blood Sugar Monitor

Participants in both groups will wear a blood sugar monitor for the duration of their participation on the study, except on the day of surgery. The monitor is worn on the participant's arm and checks the participants blood sugar every 15 minutes.

PROCEDURE

Hysterectomy

Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.

Locations (1)

University of Miami

Miami, Florida, United States