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
1 other identifier
interventional
90
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2026
CompletedFirst Posted
Study publicly available on registry
June 12, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
Study Completion
Last participant's last visit for all outcomes
February 1, 2029
June 12, 2026
June 1, 2026
2.6 years
June 8, 2026
June 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to Assigned Intermittent Fasting Regimen
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 Outcomes (1)
Incidence of Adverse Events
Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-up
Study Arms (3)
Usual Care, No Fasting
NO INTERVENTIONParticipants will receive standard nutrition education materials per institutional practice. No fasting regimen will be prescribed during immune checkpoint inhibitor (ICI) therapy.
Alternate-Day Fasting (ADF)
EXPERIMENTALParticipants 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).
Time-Restricted Eating (TRE)
EXPERIMENTALParticipants 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nour Daboul, MD
West Virginia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 8, 2026
First Posted
June 12, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
June 12, 2026
Record last verified: 2026-06