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Fasting InTervention for Endometrial Cancer (FIT-ENDO)

2026년 5월 27일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

42

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • Florida
      • Miami, Florida, 미국, 33136
        • 모병
        • University of Miami
        • 수석 연구원:
          • Navya Nair, MD
        • 수석 연구원:
          • Abdulrahman Sinno, MD
        • 수석 연구원:
          • Tracy E Crane, PhD, RDN
        • 연락하다:
        • 수석 연구원:
          • Sophia HL George, PhD
        • 부수사관:
          • Matthew Schlumbrecht, MD, MPH
        • 수석 연구원:
          • Troy A Gatliffe, MD
        • 수석 연구원:
          • Joseph Matthew Pearson, MD
        • 수석 연구원:
          • Andre Pinto, MD
        • 수석 연구원:
          • David Lombard, MD, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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.
절차: 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).
다른: 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.
다른 이름들:
  • Continuous Glucose Monitor (CGM)
절차: Hysterectomy
Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.
다른: 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.
절차: 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).
다른: 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.
다른 이름들:
  • Continuous Glucose Monitor (CGM)
절차: Hysterectomy
Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility of Recruitment: Percentage of Participants That Consent to Participate and Meet Eligibility Criteria
기간: 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.
기간: 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.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage Change in Metabolic Biomarker Levels at Post-Surgery Compared to Pre-Surgery, in the Intervention Versus Control Group
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Miami

협력자

Florida Department of Health

수사관

  • 수석 연구원: Tracy E Crane, PhD, RDN, University of Miami

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2028년 7월 1일

연구 완료 (추정된)

2028년 7월 1일

연구 등록 날짜

최초 제출

2026년 3월 20일

QC 기준을 충족하는 최초 제출

2026년 5월 27일

처음 게시됨 (실제)

2026년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 27일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 20250674

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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위치

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