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

25. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Anika Rajput, MD/PhD
  • Telefonní číslo: 004930450618599
  • E-mail: melafit@charite.de

Studijní záloha kontaktů

  • Jméno: Thomas Eigentler, Prof. Dr.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Pozorovací
Aktivní komparátor: High-Fiber Diet
Behaviorální: High-Fiber Diet
High-Fiber Diet (>35g/day) according to the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) for 6 months.
Experimentální: High-Fiber Diet and Short-Term Fasting
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Study feasability, measured by adequacy and efficiency of recruitment strategies
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Adverse events
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Waist circumference
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Charite University, Berlin, Germany

Spolupracovníci

University Hospital Heidelberg
CHUM Microbiome Research Center Montréal

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. června 2026

Primární dokončení (Odhadovaný)

5. července 2028

Dokončení studie (Odhadovaný)

5. prosince 2028

Termíny zápisu do studia

První předloženo

3. června 2026

První předloženo, které splnilo kritéria kontroly kvality

25. června 2026

První zveřejněno (Aktuální)

2. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MelaFit

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

IPD will be shared upon request.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Zdravotní podmínky

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Podmínky

Vzácné nemoci

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Místa

3
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