NCT07622901 · University of Miami
Fasting InTervention for Endometrial Cancer
(FIT-ENDO)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Miami, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations