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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Meg Zafiris
- Telefonnummer: 304-293-6065
- E-Mail: margaret.zafiris@hsc.wvu.edu
Studieren Sie die Kontaktsicherung
- Name: Joni Aldinger
- Telefonnummer: 304-293-5949
- E-Mail: jlaldinger@hsc.wvu.edu
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: 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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Experimental: 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).
|
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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Experimental: 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).
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Adherence to Assigned Intermittent Fasting Regimen
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Adverse Events
Zeitfenster: 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.
|
Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-up
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Nour Daboul, MD, West Virginia University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Männliche Urogenitalerkrankungen
- Nierenerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Neubildungen nach histologischem Typ
- Neoplasmen des Verdauungssystems
- Erkrankungen des Verdauungssystems
- Leberkrankheiten
- Neubildungen, Drüsen und Epithelien
- Adenokarzinom
- Lebertumoren
- Hautkrankheiten
- Urologische Neubildungen
- Karzinom
- Neuroektodermale Tumoren
- Neoplasmen, Keimzelle und Embryonal
- Neubildungen, Nervengewebe
- Nierentumoren
- Neuroendokrine Tumoren
- Nävi und Melanome
- Hauttumoren
- Haut- und Bindegewebserkrankungen
- Neubildungen
- Karzinom, hepatozellulär
- Karzinom, Nierenzelle
- Cholangiokarzinom
- Melanom
Andere Studien-ID-Nummern
- STUDY00000260
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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