Fasting InTervention for Endometrial Cancer

Официальное название

Fasting InTervention for Endometrial Cancer (FIT-ENDO)

Обзор

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.

Вмешательства

• Поведенческое 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
• Процедура 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).
• Другое 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.
• Процедура Hysterectomy
  Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care.

Первичные конечные точки

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

Вторичные конечные точки (9)

• Percentage Change in Metabolic Biomarker Levels at Post-Surgery Compared to Pre-Surgery, in the Intervention Versus Control Group [Срок оценки: 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 [Срок оценки: Baseline, about 28 Days]
• Change in Quality of Life As Measured By Scores on the PROMIS-29 Questionnaire [Срок оценки: Baseline, about 28 Days]
• Change in Quality of Life As Measured By Scores on the Rosenburg Self-Esteem Scale [Срок оценки: Baseline, about 28 Days]
• Change in Quality of Life As Measured By Scores on the Hopwood's Body Image Scale [Срок оценки: Baseline, about 28 Days]
• Change in Sleep Quality As Measured By Scores on the Pittsburgh Sleep Quality Index [Срок оценки: Baseline, about 28 Days]
• Change in Physical Activity As Measured By Scores on the Godin Leisure Time Exercise Questionnaire [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, about 28 Days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT07622901 · 20250674

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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