Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors

June 8, 2026 updated by: Nour Daboul, West Virginia University

Feasibility and Immunometabolic Effects of Intermittent Fasting During Immune Checkpoint Inhibitor Therapy: A Randomized Pilot Study in Advanced Solid Tumors

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

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 Contact Backup

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:

  • Diagnosis of advanced esophageal, gastric, non-small cell lung cancer (NSCLC), HCC, cholangiocarcinoma, melanoma, RCC, or MSI-H cancer

    • Planned treatment with ICI-based therapy
    • ECOG 0-2
    • Ability to provide informed consent
    • Willingness to follow dietary guidance and record adherence
    • BMI = 23-40

Exclusion Criteria:

  • Diabetes requiring insulin

    • Active eating disorders
    • Sarcopenia and/or cachexia (mild, moderate, severe), including sarcopenic obesity
    • A history of hypoglycemia, including idiopathic and postbariatric hypoglycemia
    • Patients taking sulfonylureas (concern for hypoglycemia with fasting)
    • Night shift workers (at discretion of investigator)
    • >10% weight loss within the past 3 months through self-reporting or chart review.
    • Any uncontrolled autoimmune condition or recent high-dose steroid use
    • Severe GI or endocrine disorders precluding fasting including but not limited to malabsorption syndromes, gastroparesis, or Addison's/Cushing's
    • Pregnant or breastfeeding

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care, No Fasting
Participants will receive standard nutrition education materials per institutional practice. No fasting regimen will be prescribed during immune checkpoint inhibitor (ICI) therapy.
Experimental: Alternate-Day Fasting (ADF)
Participants will follow a repeating cycle of approximately 12 hours of eating followed by 36 hours of fasting every other day during ICI therapy. During fasting periods, participants may consume plain coffee, sugar-free tea, sugar-free herbal tea, sugar-free chewing gum, and 1-2 cups per day of clear vegetable or meat broth (up to 500 kcal/day). The fasting intervention will begin within 1 week of ICI initiation and continue for 8 cycles of therapy (approximately 20-24 weeks).
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.
Experimental: Time-Restricted Eating (TRE)
Participants will consume all daily calories within an 8-hour eating window each day during ICI therapy, typically between 10:00 AM and 6:00 PM, with flexibility to shift the window by 1 hour earlier or later. Outside the eating window, participants may consume plain coffee, tea, herbal tea, sugar-free chewing gum, and 1-2 cups per day of clear broth. The fasting intervention will begin within 1 week of ICI initiation and continue for 8 cycles of therapy (approximately 20-24 weeks).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Assigned Intermittent Fasting Regimen
Time Frame: Up to approximately 24 weeks (8 treatment cycles)

Adherence will be assessed using participant-completed fasting diaries. For the time-restricted eating (TRE) arm, adherence is defined as meeting the assigned fasting window on ≥5 days per week.

For the alternate-day fasting (ADF) arm, adherence is defined as meeting fasting-day criteria on ≥5 days within each 14-day period.

Adherence will be summarized as the proportion of participants who meet the assigned regimen-specific adherence criteria during the study period.
Up to approximately 24 weeks (8 treatment cycles)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-up
Adverse events (AEs) and immune-related AEs (irAE) will be summarized and compared descriptively between study arms. Events will be graded according to CTCAE. The proportion of participants experiencing irAEs, including grade ≥3 irAEs, will be summarized by treatment group.
Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-up

Collaborators and Investigators

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

Sponsor

West Virginia University

Investigators

  • Principal Investigator: Nour Daboul, MD, West Virginia University

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)

July 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000260

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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