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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Thomas Eigentler, Prof. Dr.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Observationel
Aktiv komparator: High-Fiber Diet
Adfærdsmæssigt: High-Fiber Diet
High-Fiber Diet (>35g/day) according to the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) for 6 months.
Eksperimentel: High-Fiber Diet and Short-Term Fasting
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Study feasability, measured by adequacy and efficiency of recruitment strategies
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Waist circumference
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Charite University, Berlin, Germany

Samarbejdspartnere

University Hospital Heidelberg
CHUM Microbiome Research Center Montréal

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juni 2026

Primær færdiggørelse (Anslået)

5. juli 2028

Studieafslutning (Anslået)

5. december 2028

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MelaFit

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

IPD will be shared upon request.

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Kliniske forsøg med Melanom (hudkræft)

Kliniske forsøg med High-Fiber Diet

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