Fasting InTervention for Endometrial Cancer
FIT-ENDO
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
Study Completion
Last participant's last visit for all outcomes
July 1, 2028
June 3, 2026
May 1, 2026
2 years
March 20, 2026
May 27, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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).
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).
Up to 10 weeks
Secondary Outcomes (9)
Percentage Change in Metabolic Biomarker Levels at Post-Surgery Compared to Pre-Surgery, in the Intervention Versus Control Group
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
Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the PROMIS-29 Questionnaire
Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the Rosenburg Self-Esteem Scale
Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the Hopwood's Body Image Scale
Baseline, about 28 Days
- +4 more secondary outcomes
Study Arms (2)
Prolonged Overnight Fasting (POF) Group
EXPERIMENTALParticipants 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.
Attention Control Group
OTHERParticipants 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
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 specimens will be collected from participants at baseline (T0), the day of surgery (T1), and at six weeks post-surgery (T2).
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.
Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.
Eligibility Criteria
You may qualify if:
- Women 18 years of age or older.
- Able to provide consent.
- Able to read/understand English, Spanish or Haitian Creole.
- Have a diagnosis of Type I (low-grade) endometrial cancer at any stage, histologically confirmed prior to the start of the intervention.
- Planned minimally invasive surgical treatment (laparoscopy or robotic approach to hysterectomy).
- Approval to participate from treating oncologist, confirmed via email or in writing.
- Eastern Cooperative Oncology Group (ECOG) Performance status grade 0-2.
- Surgeries must be at one of the following institutions:
- Sylvester Comprehensive Cancer Center
- University of Miami Hospital (UHealth) Tower
- Internet access on a smart phone, tablet, or computer.
- Agree to be randomly assigned to any study group.
You may not qualify if:
- Women less than 18 years of age.
- Unable to provide consent.
- Unable to read/understand English or Spanish.
- History of prior hysterectomy.
- Any contraindication for prolonged overnight fasting of 13 hours or exercising as determined by a physician.
- Engaging in structured fasting consistently (equal to or more than 50% of the time) for \>12 hours/night.
- Presence of a severe medical or psychiatric condition or medication that would preclude participation of the study intervention, unstable cardiac disease.
- Diagnosis of diabetes treated with insulin, metformin, sulfonylureas, or Glucagon-like peptide-1 (GLP-1) agonist medications.
- 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.
- Women for whom definitive hysterectomy is not planned for treatment of their endometrial cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florida Department of Healthcollaborator
- University of Miamilead
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tracy E Crane, PhD, RDN
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 20, 2026
First Posted
June 3, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
June 3, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share