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

Number of participants recruited per month (at least 2 per month)

Adherence to the Intervention for intervention groups (at least 70% of the fasting cycles)

Patient acceptability of study assessments (number of completed study visits)

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)

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)

Frequency and severity of treatment-emergent adverse events during the study

Number of hospital admissions occurring during the study period

Frequency of dose interruption or reduction

Total cumulative dose of study treatment administered during the study period

Frequency of treatment discontinuation and the reasons for it

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)

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

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).

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).

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.

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.

Analysis of differential blood count to determine the distribution of leukocyte subtypes, including neutrophils, lymphocytes, monocytes, eosinophils, and basophils." Unit of Measure: cells/µL

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)

Alanine aminotransferase (ALT/ALAT), Unit of Measure: U/L

Aspartate aminotransferase (AST/ASAT), unit of Measure: U/L

calcium in millimol per liter (mmol/L), potassium (mmol/L), sodium (mmol/L)

Creatinine in µmol per liter (µmol/L), Biomarker of renal function and muscle metabolism

Glucose, unit of Measure: mg/dL oder mmol/L

Lactate dehydrogenase (LDH), unit of Measure: U/L

S100 protein, unit of Measure: µg/L or ng/mL

Waist circumference, unit of Measure: cm

Hip circumference, unit of Measure: cm

Body composition assessed by bioelectrical impedance analysis (BIA)

Psoas muscle density assessed from clinically indicated CT scans when available from standard clinical care

Time from study entry to disease progression or death

Time from study entry to disease recurrence or death

Time from study entry to death from any cause

Immune cell subsets quantified by flow cytometry

Ketone body concentration, Indicators of fat metabolism and ketosis, analyzed for metabolic adaptations. Unit of Measure: mmol/L

Quantification of pro- and anti-inflammatory cytokines (e.g., IL-6, IL-17, TNF-α, IL-10) using multiplex ELISA or Luminex technology.

Functional immune cell tests: Proliferation assays and cytokine production following stimulation

Gut microbiota diversity assessed by shotgun metagenomic sequencing of stool samples.