Hysterectomy Clinical Trials

Clinical trials related to Hysterectomy Procedure

Fasting InTervention for Endometrial Cancer (FIT-ENDO)

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Grey E Freylersythe, BS
g.freylersythe@med.miami.edu
305-243-9832
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 42
Treatments
Experimental: Prolonged Overnight Fasting (POF) Group
Participants 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.
Other: Attention Control Group
Participants 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.
Related Therapeutic Areas
Sponsors
Collaborators: Florida Department of Health
Leads: University of Miami

This content was sourced from clinicaltrials.gov