An interventional study of High-Fiber Diet and High-Fiber Diet and Short-Term Fasting in Melanoma (Skin Cancer), sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Other
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.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 2,649 interventional studies indexed under Melanoma.
Browse Melanoma studies →Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: High-Fiber Diet
Behavioral: High-Fiber Diet and Short-Term Fasting
High-Fiber Diet (\>35g/day) according to the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) for 6 months.
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.
Study feasability, measured by adequacy and efficiency of recruitment strategies
Number of participants recruited per month (at least 2 per month)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Adverse events
Frequency and severity of treatment-emergent adverse events during the study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Waist circumference
Waist circumference, unit of Measure: cm
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
Plan to share: No — IPD will be shared upon request.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.
Of 219 non-industry interventional studies with no phase under Melanoma, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's planned 23 months is below that.
Counting every sponsor, half of 227 studies reached it within 38 months; a quarter within 20 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
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