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.
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
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
Parallel
High-Fiber Diet
BehavioralHigh-Fiber Diet (\>35g/day) according to the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) for 6 months.
High-Fiber Diet and Short-Term Fasting
BehavioralHigh-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)
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)
Study feasability, measured by acceptability of study outcome measures
Patient acceptability of study assessments (number of completed study visits)
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)
Adverse events
Frequency and severity of treatment-emergent adverse events during the study
Hospitalizations rate
Number of hospital admissions occurring during the study period
Dose Interruption or reduction
Frequency of dose interruption or reduction
Cumulative dose
Total cumulative dose of study treatment administered during the study period
Waist circumference
Waist circumference, unit of Measure: cm
Hip circumference
Hip circumference, unit of Measure: cm
Bioimpedance measurement
Body composition assessed by bioelectrical impedance analysis (BIA)
Psoas muscle density
Psoas muscle density assessed from clinically indicated CT scans when available from standard clinical care
Click on the lead sponsor to view all of their trials.
Charite University, Berlin, Germany
Lead sponsor
University Hospital Heidelberg
Collaborator
CHUM Microbiome Research Center Montréal
Collaborator
