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NCT Number: NCT07645742

Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors

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.

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Key information

Conditions

Cancer (Advanced Stage) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Carcinoma, Renal Cell Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Alternate-Day Fasting (ADF)

Behavioral

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.

Time-Restricted Eating (TRE)

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

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

Joni Aldinger

CONTACT

[email protected]

304-293-5949

Meg Zafiris

CONTACT

[email protected]

304-293-6065

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 12, 2026
Registry last updated
Jun 12, 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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