Cancer (Advanced Stage)
Conditions
Keywords
esophogeal, gastric, lung, cholangiocarcinoma, melanoma, Hepatocellular Carcinoma, Immune Checkpoint Inhibitor, Microsatellite Instability-High, Renal Cell Carcinoma
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.
Interventions
BEHAVIORALAlternate-Day Fasting (ADF)
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.
BEHAVIORALTime-Restricted Eating (TRE)
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.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Assigned Intermittent Fasting Regimen | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 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. |
Contacts
CONTACTMeg Zafiris
CONTACTJoni Aldinger
PRINCIPAL_INVESTIGATORNour Daboul, MD
West Virginia University
Outcome results
None listed