Clinical trial for Endometrial Cancer
Official title Fasting InTervention for Endometrial Cancer
ClinicalTrials.gov ID: NCT07622901
What this study is testing
- What it's testing
- The study wants to see whether not eating overnight is safe and how it affects metabolism in women with endometrial cancer who are having surgery.
- Who it's for
- Women diagnosed with endometrial cancer who are scheduled for surgery.
- What's involved
- Participants will skip food and drink for the night before their operation and will have the usual pre‑surgery checks and lab tests.
- Time commitment
- A single overnight fast before the surgery date, with the usual pre‑operative visit.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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).
You likely can't join 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.
See the full eligibility 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.
- 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.
- 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.
- Women for whom definitive hysterectomy is not planned for treatment of their endometrial cancer.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.