Not Yet RecruitingNot Applicable

Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors

90 participantsStarted 2026-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is focused on whether patients can actually stick to an intermittent fasting schedule while on immune checkpoint inhibitors — does that mean it's too early to know if the fasting itself helps fight the cancer, and what would that mean for my treatment if I joined?
2Since this study is listed as 'not yet recruiting,' how far out do you think it might open, and is waiting for it a realistic option given where my cancer is right now?
3Immune checkpoint inhibitors can cause significant side effects on their own — could adding an intermittent fasting requirement make managing those side effects harder or more dangerous for someone in my situation?
4This is described as a pilot study with no assigned phase, which suggests it's very early-stage research — given that, do you think there's a stronger evidence-based treatment path I should pursue first before considering something like this?
5What would the actual fasting schedule look like day-to-day while I'm receiving immune checkpoint infusions, and is that something you think would be realistic for me to follow given my current health and energy levels?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adherence to Assigned Intermittent Fasting Regimen

Timeframe: Up to approximately 24 weeks (8 treatment cycles)

Trial details

NCT IDNCT07645742

SponsorWest Virginia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02

Contact for this trial

Meg Zafiris

304-293-6065 margaret.zafiris@hsc.wvu.edu

View on ClinicalTrials.gov More Cancer (Advanced Stage) trials