Clinical trial · Interventional
Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors
Feasibility and Immunometabolic Effects of Intermittent Fasting During Immune Checkpoint Inhibitor Therapy: A Randomized Pilot Study in Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer (Advanced Stage) | Malignant Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alternate-Day Fasting (ADF) | Behavioral | — | UNRESOLVED |
| Time-Restricted Eating (TRE) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Usual Care, No Fasting
- description
- Participants will receive standard nutrition education materials per institutional practice. No fasting regimen will be prescribed during immune checkpoint inhibitor (ICI) therapy.
- type
- EXPERIMENTAL
- label
- Alternate-Day Fasting (ADF)
- description
- 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).
- interventionNames
- Behavioral: Alternate-Day Fasting (ADF)
- type
- EXPERIMENTAL
- label
- Time-Restricted Eating (TRE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available