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

25 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Anika Rajput, MD/PhD
  • Numero di telefono: 004930450618599
  • Email: melafit@charite.de

Backup dei contatti dello studio

  • Nome: Thomas Eigentler, Prof. Dr.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Osservativo
Comparatore attivo: High-Fiber Diet
Comportamentale: High-Fiber Diet
High-Fiber Diet (>35g/day) according to the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) for 6 months.
Sperimentale: High-Fiber Diet and Short-Term Fasting
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Study feasability, measured by adequacy and efficiency of recruitment strategies
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Waist circumference
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Charite University, Berlin, Germany

Collaboratori

University Hospital Heidelberg
CHUM Microbiome Research Center Montréal

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 giugno 2026

Completamento primario (Stimato)

5 luglio 2028

Completamento dello studio (Stimato)

5 dicembre 2028

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MelaFit

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

IPD will be shared upon request.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Melanoma (cancro della pelle)

Prove cliniche su High-Fiber Diet

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Tunisia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
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