Fasting InTervention for Endometrial Cancer

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07622901
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prolonged Overnight Fasting (POF) — BEHAVIORAL
    Participants will be asked to not consume any calorie-containing food/drinks after 8pm and to fast at least 12 hours nightly, increasing to 14 hours gradually over the course of a week. Participants will be asked to maintain the prolonged overnight fasting (POF) for the duration of the intervention, with modifications as needed in the immediate postsurgery 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 eJournal through My Wellness Research Patients will enroll and begin the intervention 28 +/- 14 days prior to their scheduled surgery (hysterectomy) and continue for 6 weeks postsurgery.
  • Blood Specimen Collection — PROCEDURE
    Blood specimens will be collected from participants at baseline (T0), the day of surgery (T1), and at six weeks post-surgery (T2).
  • Blood Sugar Monitor — OTHER
    Participants in both groups will wear a blood sugar monitor for the duration of their participation on the study, except on the day of surgery. The monitor is worn on the participant's arm and checks the participants blood sugar every 15 minutes.
  • Hysterectomy — PROCEDURE
    Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Feasibility of Recruitment: Percentage of Participants That Consent to Participate and Meet Eligibility Criteria [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIP
University of MiamiMiamiFlorida33136

Find similar trials in Miami, FL

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Miami· Miami, FL

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