Overnight Fasting Before Endometrial Cancer Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will have participants fast overnight before a minimally invasive hysterectomy. It also includes blood tests and monitoring of blood sugar to understand metabolic changes related to fasting in endometrial cancer patients. Eligible women must be adults with type I endometrial cancer planning laparoscopy or robotic hysterectomy, and able to consent and follow the fasting protocol. Participants are randomly assigned to study groups to compare outcomes. The trial is sponsored by the University of Miami with involvement from the Florida Department of Health and is conducted at the University of Miami.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Tracy E Crane, PhD, RDN — University of Miami
• Study coordinator: Grey E Freylersythe, BS
• Email: g.freylersythe@med.miami.edu
• Phone: 305-243-9832

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.