Fasting InTervention for Endometrial Cancer

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.

Eligibility

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.

Conditions2

Locations1 site

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