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

Condition(s) studied

Investigational drug(s) / intervention(s)

High-Fiber Diet: High-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: 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 summary

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.

Eligibility

Primary outcome measure(s)

• Study feasability, measured by adequacy and efficiency of recruitment strategies — Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
  Number of participants recruited per month (at least 2 per month)
• Study feasability, measured by adherence to the intervention and dropout rate — After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
  Adherence to the Intervention for intervention groups (at least 70% of the fasting cycles)
• Study feasability, measured by acceptability of study outcome measures — Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
  Patient acceptability of study assessments (number of completed study visits)
• Feasibility of the study procedures — Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
  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 procedures — Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months
  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)

Trial sites (1)

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