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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This study uses a parallel design, where participants are randomly assigned to one of two treatment groups and remain in their designated group throughout the duration of the study: (1) Prolonged overnight fasting (POF) or (2) Attention Control. Randomization will follow a 2:1 ratio of fasting to control conditions.
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: Prolonged Overnight Fasting (POF)
    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.
  • Procedure: Blood Specimen Collection
    Blood specimens will be collected from participants at baseline (T0), the day of surgery (T1), and at six weeks post-surgery (T2).
  • Other: Blood Sugar Monitor
    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.
    Other names:
    • Continuous Glucose Monitor (CGM)
  • Procedure: Hysterectomy
    Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.
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.
  • Procedure: Blood Specimen Collection
    Blood specimens will be collected from participants at baseline (T0), the day of surgery (T1), and at six weeks post-surgery (T2).
  • Other: Blood Sugar Monitor
    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.
    Other names:
    • Continuous Glucose Monitor (CGM)
  • Procedure: Hysterectomy
    Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.

Recruiting Locations

University of Miami
Miami, Florida 33136
Contact:
Grey Freylersythe, BS
305-243-9832
g.freylersythe@med.miami.edu

More Details

Status
Recruiting
Sponsor
University of Miami

Study Contact

Grey E Freylersythe, BS
305-243-9832
g.freylersythe@med.miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.