NCT07513116

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
31mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 17, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 1, 2026

Last Update Submit

April 13, 2026

Conditions

EvaluatingIntermittent FastingPancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety and adverse events (AEs).

    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.

Study Arms (1)

Intermittent fasting

EXPERIMENTAL

Fast for 16 consecutive hours each day and have an 8-hour window for eating.

Other: intermittent fasting

Interventions

intermittent fastingOTHER

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

Intermittent fasting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Intermittent FastingPancreatic Neoplasms

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehaviorDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Florencia McAllister, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florencia McAllister, MD

CONTACT

713-745-0914fmcallister@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 6, 2026

Study Start (Estimated)

September 17, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2029

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

US(1)