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

April 13, 2026 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Florencia McAllister, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent fasting
Fast for 16 consecutive hours each day and have an 8-hour window for eating.
Other: intermittent fasting
They will fast for 16 consecutive hours each day and have an 8-hour window for eating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and adverse events (AEs).
Time Frame: 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
Through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Florencia McAllister, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 17, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2029

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0227
  • NCI-2026-02451 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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