Time Restricted Eating (TRE) Schedule for Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Huntsman Cancer Institute, Salt Lake City, UTEndometrial CancerTime Restricted Eating (TRE) Schedule - Behavioral
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trialwill test if Time Restricted Eating (TRE) can improve metabolic health and reduce cardiometabolic disease in endometrial cancer patients.

Eligible Conditions
  • Endometrial Cancer

Treatment Effectiveness

Study Objectives

5 Primary · 9 Secondary · Reporting Duration: Baseline (Visit 1), Visit 2 (Week 2), Visit 3 (Week 6 or Week 8), Visit 5 (Week 16)

Week 16
Change in BMI assessed via height and weight
Change in blood pressure assessed via electronic blood pressure monitor
Change in waist circumference assessed via measuring tape
Week 16
Attrition as a Function of Time
Fidelity of Time Restricted Eating (TRE) Intervention
Number of TRE-Adherent Days per Week
Percent of Scheduled Assessments Completed
Proportion of Women Referred that are Consented
Week 16
Change in HDL-cholesterol assessed via blood draw
Change in HOMA-IR assessed via blood draw
Change in c-peptide assessed via blood draw
Change in fasting blood glucose assessed via blood draw
Change in high sensitivity C-reactive protein assessed via blood draw
Change in triglycerides assessed via blood draw

Trial Safety

Trial Design

2 Treatment Groups

Control Schedule
1 of 2
Time Restricted Eating (TRE) Schedule
1 of 2

Active Control

Experimental Treatment

15 Total Participants · 2 Treatment Groups

Primary Treatment: Time Restricted Eating (TRE) Schedule · No Placebo Group · N/A

Time Restricted Eating (TRE) Schedule
Behavioral
Experimental Group · 1 Intervention: Time Restricted Eating (TRE) Schedule · Intervention Types: Behavioral
Control ScheduleNoIntervention Group · 1 Intervention: Control Schedule · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (visit 1), visit 2 (week 2), visit 3 (week 6 or week 8), visit 5 (week 16)

Who is running the clinical trial?

University of UtahLead Sponsor
1,009 Previous Clinical Trials
1,787,573 Total Patients Enrolled
1 Trials studying Endometrial Cancer
Mary Playdon, PhD, MPHPrincipal InvestigatorUniversity of Utah
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are considered overweight or obese based on your body mass index (BMI) being 25 or higher.
You have undergone cancer surgery and/or treatment at least 3 months ago.

Frequently Asked Questions

How many individuals are being allocated to this clinical investigation?

"Affirmative, according to clinicaltrials.gov the trial is actively recruiting subjects and was posted on October 7th 2021 before being updated most recently on November 3rd 2022. 15 individuals are required for this study which will take place at a single location." - Anonymous Online Contributor

Unverified Answer

What aims has this scientific research set out to accomplish?

"The primary goal of this medical study, with measurements taken from the beginning to Week 16, is to identify the proportion of women who agree to participate. Secondary objectives involve tracking alterations in fasting blood glucose (blood sample), electronic blood pressure monitor readings and HDL-cholesterol levels (also through a small sample)." - Anonymous Online Contributor

Unverified Answer

Is enrollment still open for this research project?

"Affirmative. The information hosted on clinicaltrials.gov specifies that the trial is open for recruitment; it was initially published on October 7th 2021 and its details were last updated November 3rd 2022. There are 15 available spots to be filled in total, all at a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.