Evaluating Intermittent Fasting In Individuals At High Risk ForPancreatic Cancer Undergoing Screening
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs).
研究概览
简要总结
To learn whether an eating pattern called intermittent fasting (IF) is tolerable and feasible for individuals at high risk of pancreatic cancer and whether IF is associated with changes in biological markers, including metabolic, inflammatory, microbiome, and imaging-related markers.
详细描述
Primary Objectives
• To assess the tolerability and feasibility of Intermittent fasting (IF) in participants at high risk for pancreatic cancer.
Secondary Objectives
- To assess changes in oral and gut microbiome after IF.
- To assess changes in metabolomic markers after IF.
- To assess changes in inflammatory markers after IF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥ 18 years old. Participants under 18 are excluded due to their potential inability to understand and consent independently to the methods required for the study drug use and its potential risks and benefits.
- •Participants evaluated and classified as high risk for pancreatic cancer through a High-Risk Pancreatic Cancer Clinic or High-Risk Pancreatic Cyst Clinic, based on established clinical assessment and risk stratification.
- •High-risk status may include one or more of the following:
- •Hereditary cancer syndromes or known pathogenic germline mutations associated with pancreatic cancer risk
- •Family history of pancreatic ductal adenocarcinoma (PDAC)
- •Presence of pancreatic cysts or precursor lesions (e.g., IPMN, MCN)
- •New-onset diabetes mellitus is considered suspicious for pancreatic cancer
- •History of recurrent or chronic pancreatitis
- •Eligibility and surveillance risk assessment must be consistent with NCCN (National Comprehensive Cancer Network) Guidelines for Pancreatic Cancer Screening in High- Risk Individuals.
- •Participants are able to understand and are willing to sign a written informed consent document.
- •Both English-speaking and non-English-speaking participants are eligible for participation
- •Participants are willing to make a change in eating time patterns.
- •Participants are willing to provide App-tracked fasting time data over the course of the study.
排除标准
- •BMI < 18.5 Kg/m2
- •Documented history of symptomatic hypoglycemia
- •Pregnant or breastfeeding women
- •Cognitively impaired individuals
研究组 & 干预措施
Intermittent fasting
Fast for 16 consecutive hours each day and have an 8-hour window for eating.
干预措施: intermittent fasting (Other)
结局指标
主要结局
Safety and adverse events (AEs).
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点