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NCT Number: NCT07513116

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location contact

Florencia McAllister, MD

CONTACT

[email protected]

713-745-0914

Florencia McAllister, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intermittent fasting

Other

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Florencia McAllister, MD

CONTACT

[email protected]

713-745-0914

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Apr 6, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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