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
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Meg Zafiris
- Telefoonnummer: 304-293-6065
- E-mail: margaret.zafiris@hsc.wvu.edu
Studie Contact Back-up
- Naam: Joni Aldinger
- Telefoonnummer: 304-293-5949
- E-mail: jlaldinger@hsc.wvu.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Usual Care, No Fasting
Participants will receive standard nutrition education materials per institutional practice.
No fasting regimen will be prescribed during immune checkpoint inhibitor (ICI) therapy.
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Experimenteel: Alternate-Day Fasting (ADF)
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).
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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.
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Experimenteel: Time-Restricted Eating (TRE)
Participants 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).
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Adherence to Assigned Intermittent Fasting Regimen
Tijdsspanne: Up to approximately 24 weeks (8 treatment cycles)
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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)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of Adverse Events
Tijdsspanne: Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-up
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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.
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Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-up
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Nour Daboul, MD, West Virginia University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Urogenitale neoplasmata
- Neoplasmata per site
- Mannelijke urogenitale ziekten
- Nier Ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Neoplasmata per histologisch type
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Lever Ziekten
- Neoplasmata, glandulair en epitheel
- Adenocarcinoom
- Lever neoplasmata
- Huidziektes
- Urologische neoplasmata
- Carcinoom
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Nierneoplasmata
- Neuro-endocriene tumoren
- Nevi en melanomen
- Huidneoplasmata
- Huid- en bindweefselaandoeningen
- Neoplasmata
- Carcinoom, hepatocellulair
- Carcinoom, niercel
- Cholangiocarcinoom
- Melanoma
Andere studie-ID-nummers
- STUDY00000260
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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