RecruitingInterventional

Fasting InTervention for Endometrial Cancer (FIT-ENDO)

NCT ID: NCT07622901Sponsor: University of MiamiLast updated: 2026-06-03

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.

Arms & interventions

BehavioralProlonged 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.
ProcedureBlood Specimen Collection
Blood specimens will be collected from participants at baseline (T0), the day of surgery (T1), and at six weeks post-surgery (T2).
OtherBlood 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.
ProcedureHysterectomy
Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.

Outcome measures

Primary

Feasibility of Recruitment: Percentage of Participants That Consent to Participate and Meet Eligibility Criteria
Feasibility of recruitment will reported as the percentage of participants who consent to participate and meet eligibility criteria. Criterion for success: At least (≥) 50% of all eligible participants at Baseline (T0) consent to participate between both arms.
Time frame: Baseline
Feasibility of Retention: Percentage of Participants Who Adhere to and Complete the Intervention and Data Collection at All Time Points.
Feasibility of retention will be reported as the percentage of participants who adhere to and complete the prolonged overnight fasting (POF) intervention and data collection at all time points. Criterion for success: Greater than (\>) 70% of all assigned participants complete the intervention and data collection at all time points (T2).
Time frame: Up to 10 weeks
Acceptability: Percentage of Participants Who Report Satisfaction with the Intervention.
Acceptability will be reported as the percentage of participants who report satisfaction with the prolonged overnight fasting (POF) intervention after completion. Criterion for success: Greater than (\>) 80% of all assigned participants report satisfaction with the intervention at the time of study completion (T2).
Time frame: Up to 10 weeks

Secondary

Percentage Change in Metabolic Biomarker Levels at Post-Surgery Compared to Pre-Surgery, in the Intervention Versus Control Group
Time frame: Baseline, about 28 Days
Fold Change in Concentration of Blood and Serum Metabolomics at Post-Surgery compared to Pre-Surgery in the Intervention Versus Control Group
Time frame: Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the PROMIS-29 Questionnaire
Time frame: Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the Rosenburg Self-Esteem Scale
Time frame: Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the Hopwood's Body Image Scale
Time frame: Baseline, about 28 Days
Change in Sleep Quality As Measured By Scores on the Pittsburgh Sleep Quality Index
Time frame: Baseline, about 28 Days
Change in Physical Activity As Measured By Scores on the Godin Leisure Time Exercise Questionnaire
Time frame: Baseline, about 28 Days
Change in Diet Quality and Composition As Measured By Responses on the Automated Self-Administered 24 Hour (ASA-24) Dietary Assessment
Time frame: Baseline, about 28 days
Change in Incidence of Symptoms Related to Chemotoxicities and Side Effects from Treatment As Measured By Scores on the PRO-CTCAE Questionnaire
Time frame: Baseline, about 28 Days

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

University of Miami

Miami, Florida, 33136

Recruiting

Grey Freylersythe, BS · Contact

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

Tracy E Crane, PhD, RDN · Principal Investigator

Matthew Schlumbrecht, MD, MPH · Sub Investigator

Sophia HL George, PhD · Principal Investigator

Troy A Gatliffe, MD · Principal Investigator

Abdulrahman Sinno, MD · Principal Investigator

Joseph Matthew Pearson, MD · Principal Investigator

Navya Nair, MD · Principal Investigator

Andre Pinto, MD · Principal Investigator

David Lombard, MD, PhD · Principal Investigator