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Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition (Melafit)

25. Juni 2026 aktualisiert von: Anika Hartmann Rajput, MD/PhD, Charite University, Berlin, Germany

Exploratory Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition

The treatment of melanoma has improved significantly in recent years. A modern form of cancer treatment known as immunotherapy with checkpoint inhibitors plays a key role in this. These drugs help the immune system better recognize and fight cancer cells. Nevertheless, it remains a challenge to maximize treatment effectiveness while minimizing side effects.

One possible approach to influencing treatment efficacy and tolerability is diet. A high-fiber diet, as recommended by the German Nutrition Society, increases the effectiveness of immunotherapy, in part through its influence on gut bacteria (the gut microbiota). Initial studies also show that short-term fasting (i.e., eating nothing or very little for a limited period) reduces the side effects of immunotherapy in mouse models and improves the tolerability of chemotherapy in humans.

This study investigates the feasability of a study on short-term fasting, in addition to a high-fiber diet in patiens with melanoma undergoing immunotherapy.

40 participants will follow a high-fiber diet based on the recommendations of the German Nutrition Society. Additionally, half of the participants will undergo periodic cycles of short-term fasting of 72h with each immunotherapy. Another 20 participants will not undergo any intervention and serve as a control group.

The goal is to determine whether this study concept is feasible. Exploratory outcomes include, quality of life, fatigue, tolerability of the therapy, impact on disease progression, immune system (flow cytometry) and gut bacteria (microbiome).

The results are intended to help understand whether targeted dietary measures can support the effectiveness of modern cancer treatments.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Thomas Eigentler, Prof. Dr.

Studienorte

  • Deutschland
    • State of Berlin
      • Berlin, State of Berlin, Deutschland, 10117
        • Charité - Universitätsmedizin Berlin

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Histologically or cytologically confirmed stage IIB-IIIC melanoma
  • Indication for immune checkpoint inhibition as monotherapy as determined by the tumor board
  • No prior systemic melanoma therapy
  • ECOG 0 or 1
  • ≥ 18 years of age

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Underweight (BMI ≤19.5)
  • Pre-existing eating disorder
  • Severe internal medical conditions (e.g., renal insufficiency with creatinine > 2 mg/dL) or secondary malignancy
  • Current vegan diet or prolonged fasting (≤ 4 days) within the last 6 months
  • Use of antibiotics within 4 weeks prior to the start of the study intervention

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Beobachtungs
Aktiver Komparator: High-Fiber Diet
Verhalten: High-Fiber Diet
High-Fiber Diet (>35g/day) according to the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) for 6 months.
Experimental: High-Fiber Diet and Short-Term Fasting
Verhalten: High-Fiber Diet and Short-Term Fasting
High-Fiber Diet (>35g/day) according to the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) and 72 hours of short-term fasting (max 400kcal/day) with every immunetherapy cycle for 6 months.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Study feasability, measured by adequacy and efficiency of recruitment strategies
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Number of participants recruited per month (at least 2 per month)
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Study feasability, measured by adherence to the intervention and dropout rate
Zeitfenster: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Adherence to the Intervention for intervention groups (at least 70% of the fasting cycles)
After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Study feasability, measured by acceptability of study outcome measures
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Patient acceptability of study assessments (number of completed study visits)
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Feasibility of the study procedures
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Feasibility of study procedures, e.g. in terms of patient and provider acceptance of randomisation and outcome measures (percentage of eligible participants who explicitly refuse to participate because of the randomization process, missing item-level data, completion rates of questionnaires)
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Feasibility of the intervention procedures
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Feasibility of the intervention methods (including patient acceptance of video and telephone consultations measured by no-show rate, patient safety in terms of number of adverse events)
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adverse events
Zeitfenster: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Frequency and severity of treatment-emergent adverse events during the study
After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Hospitalizations rate
Zeitfenster: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Number of hospital admissions occurring during the study period
After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Dose Interruption or reduction
Zeitfenster: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Frequency of dose interruption or reduction
After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Cumulative dose
Zeitfenster: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Total cumulative dose of study treatment administered during the study period
After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Treatment discontinuation
Zeitfenster: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Frequency of treatment discontinuation and the reasons for it
After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Subjective Severity of the main symptom
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Patient-reported severity of the main symptom assessed using a Visual Analog Scale (VAS) ranging from 0 (no symptoms) to 100 (worst imaginable symptom severity)
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Distress Thermometer
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Psychological distress assessed using the Distress Thermometer, a self-report scale ranging from 0 (no distress) to 10 (extreme distress). The DT is accompanied by a Problem list that identifies practical, family, emotional, spiritual/religious, and physical concerns
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Health status (EQ-5D-5L)
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Health status assessed using the EQ-5D-5L questionnaire. It evaluates five dimensions (mobilty, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated at five levels (no problems, slight problems, moderate problems, severe problems and extreme problems).
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Short Form 36
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Change in health-related quality of life assessed using the Short Form-36 (SF-36). The instrument evaluates eight domains of physical and mental health, with higher scores indicating better quality of life (scale 0-100).
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Quality of life of cancer patients (EORTC QLQ-C30)
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Quality of life of cancer patients assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The instrument comprises 30 items evaluating global health status/quality of life, functional domains (physical, role, emotional, cognitive, and social functioning), and symptom domains. Higher scores on functional and global health status scales indicate better functioning and quality of life, whereas higher symptom scores indicate greater symptom burden.
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Nutrition
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Dietary intake assessed using a 3-day food diary and using a validated Food Frequency Questionnaire (FFQ). The questionnaire evaluates the usual frequency of consumption of a range of food and beverage items over the specified recall period. Data are used to characterize dietary patterns and estimate intake of major food groups and nutrients.
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Differential blood count
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Analysis of differential blood count to determine the distribution of leukocyte subtypes, including neutrophils, lymphocytes, monocytes, eosinophils, and basophils." Unit of Measure: cells/µL
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
C-reactive protein (CRP)
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

CRP (C-reactive protein) as a marker of inflammatory conditions is used to assess acute inflammation and monitor the effects of prolonged fasting and plant-based nutrition. Higher scores indicate more inflammation.

Serum CRP, unit of Measure: CRP in milligram per liter (mg/L)
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Alanine aminotransferase (ALT/ALAT)
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Alanine aminotransferase (ALT/ALAT), Unit of Measure: U/L
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Aspartate aminotransferase (AST/ASAT)
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Aspartate aminotransferase (AST/ASAT), unit of Measure: U/L
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Electrolytes
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
calcium in millimol per liter (mmol/L), potassium (mmol/L), sodium (mmol/L)
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Creatinine
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Creatinine in µmol per liter (µmol/L), Biomarker of renal function and muscle metabolism
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Glucose
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Glucose, unit of Measure: mg/dL oder mmol/L
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Lactate dehydrogenase (LDH)
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Lactate dehydrogenase (LDH), unit of Measure: U/L
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
S100 protein
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
S100 protein, unit of Measure: µg/L or ng/mL
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Waist circumference
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Waist circumference, unit of Measure: cm
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Hip circumference
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Hip circumference, unit of Measure: cm
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Bioimpedance measurement
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Body composition assessed by bioelectrical impedance analysis (BIA)
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Psoas muscle density
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Psoas muscle density assessed from clinically indicated CT scans when available from standard clinical care
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Progression-free survival (PFS)
Zeitfenster: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Time from study entry to disease progression or death
After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Recurrence-free survival (RFS)
Zeitfenster: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Time from study entry to disease recurrence or death
After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Overall survival (OS)
Zeitfenster: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Time from study entry to death from any cause
After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Flow cytometry
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Immune cell subsets quantified by flow cytometry
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Ketone bodies
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Ketone body concentration, Indicators of fat metabolism and ketosis, analyzed for metabolic adaptations. Unit of Measure: mmol/L
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Cytokine profile
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Quantification of pro- and anti-inflammatory cytokines (e.g., IL-6, IL-17, TNF-α, IL-10) using multiplex ELISA or Luminex technology.
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Immune cell proliferation and Stimulated cytokine production
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Functional immune cell tests: Proliferation assays and cytokine production following stimulation
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Gut microbiota diversity
Zeitfenster: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Gut microbiota diversity assessed by shotgun metagenomic sequencing of stool samples.
Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Charite University, Berlin, Germany

Mitarbeiter

University Hospital Heidelberg
CHUM Microbiome Research Center Montréal

Ermittler

  • Hauptermittler: Anika Rajput, MD/PhD, Charité - Universitätsmedizin Berlin, Department of Dermatology, Venerology and Allergology

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. Juni 2026

Primärer Abschluss (Geschätzt)

5. Juli 2028

Studienabschluss (Geschätzt)

5. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

3. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MelaFit

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

IPD will be shared upon request.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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