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| Name | Class |
|---|---|
| University Hospital Heidelberg | OTHER |
| CHUM Microbiome Research Center Montréal | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Fiber Diet | Active Comparator |
| |
| High-Fiber Diet and Short-Term Fasting | Experimental |
| |
| Observational | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Fiber Diet | Behavioral | High-Fiber Diet (>35g/day) according to the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) for 6 months. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anika Rajput, MD/PhD | Contact | 004930450618599 | melafit@charite.de | |
| Thomas Eigentler, Prof. Dr. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Anika Rajput, MD/PhD | Charité - Universitätsmedizin Berlin, Department of Dermatology, Venerology and Allergology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | State of Berlin | 10117 | Germany |
IPD will be shared upon request.
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D005215 | Fasting |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| High-Fiber Diet and Short-Term Fasting | Behavioral | 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. |
|
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 |
| 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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |