Intermittent fasting in people at high risk for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the tolerability and feasibility of an intermittent fasting pattern in adults at high risk for pancreatic cancer. Researchers will monitor changes in oral and gut microbiome, metabolomic markers, inflammatory markers, and imaging-related biomarkers to understand potential biological effects. The trial does not specify a control group and focuses on feasibility and biomarker shifts associated with the eating pattern. Participants will undergo screening and follow-up assessments at MD Anderson Cancer Center in Houston, Texas. The study aims to inform whether IF could be a practical component of risk management in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria

* 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.

Exclusion Criteria

* BMI \< 18.5 Kg/m2
* Documented history of symptomatic hypoglycemia
* Pregnant or breastfeeding women
* Cognitively impaired individuals

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Florencia McAllister, MD — M.D. Anderson Cancer Center
• Study coordinator: Florencia McAllister, MD
• Email: fmcallister@mdanderson.org
• Phone: 713-745-0914

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.