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

RecruitingNAAges 18 Years - anyAllCharite University, Berlin, Germany
NCT07680452 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * ≥ 18 years of age Exclusion Criteria: * 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 * Current vegan diet or prolonged fasting (≤ 4 days) within the last 6 months * Use of antibiotics within 4 weeks prior to the start of the study intervention
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What it tests

  • High-Fiber Diet
  • High-Fiber Diet and Short-Term Fasting
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Where

1 site
Charité - Universitätsmedizin Berlin
Berlin, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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