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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma (Skin Cancer)
• Intervention / Treatment: Behavioral: High-Fiber Diet; Behavioral: High-Fiber Diet and Short-Term Fasting

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anika Rajput, MD/PhD; Phone Number: 004930450618599; Email: melafit@charite.de
• Study Contact Backup: Name: Thomas Eigentler, Prof. Dr.

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observational
Active Comparator: High-Fiber Diet	Behavioral: 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	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study feasability, measured by adequacy and efficiency of recruitment strategies	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	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	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	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	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	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	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	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	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)	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	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)	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	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	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)	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)	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)	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	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	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	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)	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	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	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	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	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)	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)	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)	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: University Hospital Heidelberg; CHUM Microbiome Research Center Montréal
• Investigators: Principal Investigator: Anika Rajput, MD/PhD, Charité - Universitätsmedizin Berlin, Department of Dermatology, Venerology and Allergology

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): July 5, 2028
• Study Completion (Estimated): December 5, 2028

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: immunotherapy; diet; melanoma; microbiome; fasting; fiber; short-term fasting; high-fiber; STF; checkpoint-inhibitor; checkpoint-inhibition
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Behavior; Skin and Connective Tissue Diseases; Feeding Behavior; Melanoma; Fasting; Intermittent Fasting
• Other Study ID Numbers: MelaFit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No