Recruiting

Fasting

Sponsor:

University of Miami

Code:

NCT07622901

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prolonged Overnight Fasting (POF)

Blood Specimen Collection

Blood Sugar Monitor

Hysterectomy

Study Details

Brief 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

Endometrial Cancer

Study ID

NCT07622901

Start date

Feb 27, 2026

Status verified date

Jul, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Women 18 years of age or older.
2. Able to provide consent.
3. Able to read/understand English, Spanish or Haitian Creole.
4. Have a diagnosis of Type I (low-grade) endometrial cancer at any stage, histologically confirmed prior to the start of the intervention.
5. Planned minimally invasive surgical treatment (laparoscopy or robotic approach to hysterectomy).
6. Approval to participate from treating oncologist, confirmed via email or in writing.
7. Eastern Cooperative Oncology Group (ECOG) Performance status grade 0-2.
8. Surgeries must be at one of the following institutions:

1. Sylvester Comprehensive Cancer Center
2. University of Miami Hospital (UHealth) Tower
9. Internet access on a smart phone, tablet, or computer.
10. Agree to be randomly assigned to any study group.

Exclusion Criteria:

1. Women less than 18 years of age.
2. Unable to provide consent.
3. Unable to read/understand English or Spanish.
4. History of prior hysterectomy.
5. Any contraindication for prolonged overnight fasting of 13 hours or exercising as determined by a physician.
6. Engaging in structured fasting consistently (equal to or more than 50% of the time) for >12 hours/night.
7. Presence of a severe medical or psychiatric condition or medication that would preclude participation of the study intervention, unstable cardiac disease.
8. Diagnosis of diabetes treated with insulin, metformin, sulfonylureas, or Glucagon-like peptide-1 (GLP-1) agonist medications.
9. Recent history of a clinical eating disorder as determined by self-report, medical history, or clinical judgement. Participants with a history of an eating disorder that is well-managed and in sustained remission may be eligible, subject to investigator discretion.
10. Women for whom definitive hysterectomy is not planned for treatment of their endometrial cancer.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Prolonged Overnight Fasting (POF) Group

Participants in this group will begin and be asked to maintain a prolonged overnight fasting (POF) plan for the duration of the intervention, with modifications as needed in the immediate post-surgery 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 electronic journal (eJournal) through the University of Miami's My Wellness Research app.

Participants will meet with a nutrition health coach weekly by video or phone call. Participants will also under blood specimen collections, wear a blood sugar monitor and physical activity tracker, and complete various symptom assessment and quality of life questionnaires.

Total participation duration is about 10 weeks.

other: Attention Control Group

Participants randomly assigned to this group will receive general health coaching video or telephone calls weekly for the duration of the study (3 weeks prior to surgery to 6 weeks post-surgery). Sessions will last approximately 15-20 minutes each time.

Participants will also undergo blood specimen collections, wear a blood sugar monitor and physical activity tracker, and complete various symptom assessments and quality of life questionnaires. At the end of the study, participants will receive a physical activity tracker and study notebooks.

Total participation duration is about 10 weeks.

Interventions

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.

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).

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.

Hysterectomy

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

Primary outcome measure

  • Feasibility of Recruitment: Percentage of Participants That Consent to Participate and Meet Eligibility Criteria [ Time Frame: Baseline ]
  • Feasibility of Retention: Percentage of Participants Who Adhere to and Complete the Intervention and Data Collection at All Time Points. [ Time Frame: Up to 10 weeks ]
  • Acceptability: Percentage of Participants Who Report Satisfaction with the Intervention. [ Time Frame: Up to 10 weeks ]

Central Contacts and Locations

Central contacts

Grey E Freylersythe, BS

305-243-9832g.freylersythe@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Grey Freylersythe, BS

305-243-9832g.freylersythe@med.miami.edu

Principal Investigator:

Tracy E Crane, PhD, RDN

More Information

Sponsor

University of Miami

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-14.