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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Alternate-Day Fasting (ADF)
BehavioralParticipants 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)
BehavioralParticipants 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Usual Care, No FastingNo intervention 0 interventions
Group B: Alternate-Day Fasting (ADF)Experimental treatment 1 intervention
Group C: Time-Restricted Eating (TRE)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Up to approximately 24 weeks (8 treatment cycles)Secondary outcomes
1
Incidence of Adverse Events
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.
Time frame
Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: