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Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors

NCT07645742 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-06-12

No results posted yet for this study

Summary

This single-site, randomized pilot study will evaluate whether intermittent fasting is feasible and safe for patients with advanced solid tumors who are starting immune checkpoint inhibitor (ICI) therapy at the WVU Cancer Institute. Participants will be assigned to 1 of 3 groups: usual care with no fasting, alternate-day fasting (ADF), or time-restricted eating (TRE).

Participants in the ADF group will follow cycles of 12 hours of eating followed by 36 hours of fasting every other day. Participants in the TRE group will eat all daily calories within an 8-hour window each day. The fasting intervention will begin within 1 week of starting ICI treatment and continue for approximately 20-24 weeks during 8 cycles of therapy.

The study will evaluate adherence to the fasting regimens and compare side effects between groups. Researchers will also study changes in metabolic and immune biomarkers, fatigue, sleep, and quality of life. Participants will be followed for 30 days after completion of the intervention to monitor safety and tolerability.

Conditions

  • Cancer (Advanced Stage)

Interventions

BEHAVIORAL

Alternate-Day Fasting (ADF)

Participants will follow an alternate-day fasting regimen during ICI therapy consisting of approximately 12 hours of eating followed by 36 hours of fasting every other day.

BEHAVIORAL

Time-Restricted Eating (TRE)

Participants will follow a time-restricted eating regimen during ICI therapy by consuming all daily calories within an 8-hour window each day, typically between 10:00 AM and 6:00 PM, with flexibility to shift the window by 1 hour earlier or later.

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • Nour Daboul, MD · West Virginia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-02-28
Completion
2029-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645742 on ClinicalTrials.gov