Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors
ConditionCancer (Advanced Stage)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest Virginia University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Alternate-Day Fasting (ADF)
- Time-Restricted Eating (TRE)
Treatment groups
90 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov