Набор скоро начнётся NCT07513116

Evaluating Intermittent Fasting In Individuals At High Risk ForPancreatic Cancer Undergoing Screening

Без фазы С лечением Evaluating Intermittent Fasting Pancreatic Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: intermittent fasting.
Кому может быть актуально: Состояния в реестре: Evaluating, Intermittent Fasting, Pancreatic Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Другое intermittent fasting
They will fast for 16 consecutive hours each day and have an 8-hour window for eating.

Первичные конечные точки

Safety and adverse events (AEs). [Срок оценки: Through study completion; an average of 1 year.]

Критерии участия

Критерии включения

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.