Fasting InTervention for Endometrial Cancer (FIT-ENDO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Blood Sugar Monitor (Other)
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.
干预措施: Hysterectomy (Procedure)
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.
干预措施: Blood Specimen Collection (Procedure)
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.
干预措施: Blood Sugar Monitor (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.
干预措施: Hysterectomy (Procedure)
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.
干预措施: Prolonged Overnight Fasting (POF) (Behavioral)
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.
干预措施: Blood Specimen Collection (Procedure)
研究者
Tracy E Crane, PhD, RDN
Associate Professor
University of Miami