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Fasting InTervention for Endometrial Cancer (FIT-ENDO)

27. maj 2026 opdateret af: Tracy E Crane, PhD, RDN, University of Miami

Fasting InTervention for Endometrial Cancer (FIT-ENDO)

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Rekruttering
        • University of Miami
        • Ledende efterforsker:
          • Navya Nair, MD
        • Ledende efterforsker:
          • Abdulrahman Sinno, MD
        • Ledende efterforsker:
          • Tracy E Crane, PhD, RDN
        • Kontakt:
        • Ledende efterforsker:
          • Sophia HL George, PhD
        • Underforsker:
          • Matthew Schlumbrecht, MD, MPH
        • Ledende efterforsker:
          • Troy A Gatliffe, MD
        • Ledende efterforsker:
          • Joseph Matthew Pearson, MD
        • Ledende efterforsker:
          • Andre Pinto, MD
        • Ledende efterforsker:
          • David Lombard, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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).
Andet: 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.
Andre navne:
  • Continuous Glucose Monitor (CGM)
Procedure: Hysterectomy
Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.
Andet: 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).
Andet: 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.
Andre navne:
  • Continuous Glucose Monitor (CGM)
Procedure: Hysterectomy
Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of Recruitment: Percentage of Participants That Consent to Participate and Meet Eligibility Criteria
Tidsramme: Baseline
Feasibility of recruitment will reported as the percentage of participants who consent to participate and meet eligibility criteria. Criterion for success: At least (≥) 50% of all eligible participants at Baseline (T0) consent to participate between both arms.
Baseline
Feasibility of Retention: Percentage of Participants Who Adhere to and Complete the Intervention and Data Collection at All Time Points.
Tidsramme: Up to 10 weeks
Feasibility of retention will be reported as the percentage of participants who adhere to and complete the prolonged overnight fasting (POF) intervention and data collection at all time points. Criterion for success: Greater than (>) 70% of all assigned participants complete the intervention and data collection at all time points (T2).
Up to 10 weeks
Acceptability: Percentage of Participants Who Report Satisfaction with the Intervention.
Tidsramme: Up to 10 weeks
Acceptability will be reported as the percentage of participants who report satisfaction with the prolonged overnight fasting (POF) intervention after completion. Criterion for success: Greater than (>) 80% of all assigned participants report satisfaction with the intervention at the time of study completion (T2).
Up to 10 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Change in Metabolic Biomarker Levels at Post-Surgery Compared to Pre-Surgery, in the Intervention Versus Control Group
Tidsramme: Baseline, about 28 Days
Change in metabolic biomarker levels (insulin, glucose, IGF-1, HbA1c) at post-surgery compared to pre-surgery, among participants in both the prolonged overnight fasting (POF) intervention and attention control groups. Blood specimens collected at baseline (T0), the day of surgery (T1) will be used to analyze changes in metabolic biomarker levels.
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
Tidsramme: Baseline, about 28 Days
Fold change in concentration of blood and serum metabolomics (> 450 water-soluble metabolites and 600 lipid-related metabolites) at post-surgery compared to pre-surgery will be reported among participants in both the prolonged overnight fasting (POF) intervention and attention control groups. Blood specimens collected at baseline (T0), the day of surgery (T1) will be analyzed using Mass Spectrometry (MS) or Nuclear Magnetic Resonance (NMR). Fold Change (FC) represents the ratio of the average metabolite concentration at post-surgery compared to pre-surgery.
Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the PROMIS-29 Questionnaire
Tidsramme: Baseline, about 28 Days
Change in participant quality of life in both the intervention and control groups as measured by scores on the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire will be reported. PROMIS-29 questionnaire is a 29-item validated measure with seven domains of health, including physical function, anxiety, depression, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities and pain intensity. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1). Higher scores represent worse symptoms for symptom-oriented domains (anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance) and better health outcomes for function-oriented domains (physical functioning and ability to participate in social roles and activities).
Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the Rosenburg Self-Esteem Scale
Tidsramme: Baseline, about 28 Days
Change in participant quality of life in both the intervention and control groups as measured by the Rosenburg Self-Esteem Scale will be reported. The Rosenberg Self-Esteem Scale (RSES) is a 10-item self-report questionnaire measuring global self-worth and self-acceptance. It uses a 4-point Likert scale (strongly agree to strongly disagree), with scores ranging from 0-30 (or 10-40). Scores below 15 indicate low self-esteem. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1).
Baseline, about 28 Days
Change in Quality of Life As Measured By Scores on the Hopwood's Body Image Scale
Tidsramme: Baseline, about 28 Days
Change in participant quality of life in both the intervention and control groups as measured by scores on the Hopwood's Body Image Scale will be reported. The Hopwood's Body Image Scale is a 10-item questionnaire used to measure affective, behavioral, and cognitive body image symptoms. Participants can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1).
Baseline, about 28 Days
Change in Sleep Quality As Measured By Scores on the Pittsburgh Sleep Quality Index
Tidsramme: Baseline, about 28 Days
Change in participant quality of life in both the intervention and control groups as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) questionnaire will be reported. The PSQI is a self-administered questionnaire for evaluating subjective sleep quality. PSQI global scores range from 0 to 21, with higher scores indicating worse sleep quality. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1).
Baseline, about 28 Days
Change in Physical Activity As Measured By Scores on the Godin Leisure Time Exercise Questionnaire
Tidsramme: Baseline, about 28 Days
Change in participant quality of life in both the intervention and control groups as measured by the Godin Leisure Time Exercise Questionnaire will be reported. The Godin Leisure Time Exercise Questionnaire assesses participants' frequency of leisure activity/exercise (strenuous, moderate or light) for more than 15 minutes during a 7-day period. Higher scores indicate a more active lifestyle. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1).
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
Tidsramme: Baseline, about 28 days
Change in participant diet quality, in both the intervention and control groups, as measured by the Automated Self-Administered (ASA-24) dietary assessment questionnaire will be reported. The ASA-24 asks respondents about everything they ate and drank the previous day or in the last 24 hours. Responses collected at baseline (T0) will be compared to responses collected the day of surgery (T1).
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
Tidsramme: Baseline, about 28 Days
Change in incidence of symptoms related to chemotoxicities and side effects from treatment among study participants on both arm as measured by scores on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. The PRO-CTCAE was developed by the National Cancer Institute (NCI) to assess symptomatic adverse events (AEs) in adult patients receiving cancer therapy. The PRO-CTCAE is a self-administered questionnaire. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1).
Baseline, about 28 Days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Miami

Samarbejdspartnere

Florida Department of Health

Efterforskere

  • Ledende efterforsker: Tracy E Crane, PhD, RDN, University of Miami

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2028

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

20. marts 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20250674

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