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Fasting InTervention for Endometrial Cancer

NCT07622901 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-07-14

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Florida Department of Health

    collaborator OTHER_GOV

  • University of Miami

    lead OTHER

Principal Investigators

  • Tracy E Crane, PhD, RDN · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-27
Primary Completion
2028-02-28
Completion
2028-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622901 on ClinicalTrials.gov