Fasting InTervention for Endometrial Cancer

Official title

Fasting InTervention for Endometrial Cancer (FIT-ENDO)

Overview

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.

Interventions

• 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 resear
• 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.
• Procedure Hysterectomy
  Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.

Primary outcome measures

• Feasibility of Recruitment: Percentage of Participants That Consent to Participate and Meet Eligibility Criteria [Time frame: Baseline]
• Feasibility of Retention: Percentage of Participants Who Adhere to and Complete the Intervention and Data Collection at All Time Points. [Time frame: Up to 10 weeks]
• Acceptability: Percentage of Participants Who Report Satisfaction with the Intervention. [Time frame: Up to 10 weeks]

Secondary outcome measures (9)

• Percentage Change in Metabolic Biomarker Levels at Post-Surgery Compared to Pre-Surgery, in the Intervention Versus Control Group [Time frame: Baseline, about 28 Days]
• Fold Change in Concentration of Blood and Serum Metabolomics at Post-Surgery compared to Pre-Surgery in the Intervention Versus Control Group [Time frame: Baseline, about 28 Days]
• Change in Quality of Life As Measured By Scores on the PROMIS-29 Questionnaire [Time frame: Baseline, about 28 Days]
• Change in Quality of Life As Measured By Scores on the Rosenburg Self-Esteem Scale [Time frame: Baseline, about 28 Days]
• Change in Quality of Life As Measured By Scores on the Hopwood's Body Image Scale [Time frame: Baseline, about 28 Days]
• Change in Sleep Quality As Measured By Scores on the Pittsburgh Sleep Quality Index [Time frame: Baseline, about 28 Days]
• Change in Physical Activity As Measured By Scores on the Godin Leisure Time Exercise Questionnaire [Time frame: Baseline, about 28 Days]
• Change in Diet Quality and Composition As Measured By Responses on the Automated Self-Administered 24 Hour (ASA-24) Dietary Assessment [Time frame: Baseline, about 28 days]
• Change in Incidence of Symptoms Related to Chemotoxicities and Side Effects from Treatment As Measured By Scores on the PRO-CTCAE Questionnaire [Time frame: Baseline, about 28 Days]

Eligibility criteria

Inclusion 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.
• 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.

Exclusion criteria

• 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. Participants with a history of an eating disorder that is well-managed and in sustained remission may be eligible, subject to investigator discretion.
• Women for whom definitive hysterectomy is not planned for treatment of their endometrial cancer.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Miami — Miami

Identifiers

NCT: NCT07622901 · 20250674

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗