NCT07680452 Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition
| NCT ID | NCT07680452 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Melanoma (Skin Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-07-28 |
| Primary Completion | 2028-07-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-07-28 with a primary completion date of 2028-07-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Anika Rajput, MD/PhD
PRINCIPAL INVESTIGATOR
Charité - Universitätsmedizin Berlin, Department of Dermatology, Venerology and Allergology
Frequently Asked Questions
Who can join the NCT07680452 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma (Skin Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07680452 currently recruiting?
Yes, NCT07680452 is actively recruiting participants. Contact the research team at melafit@charite.de for enrollment information.
Where is the NCT07680452 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07680452 clinical trial?
NCT07680452 is sponsored by Charite University, Berlin, Germany. The principal investigator is Anika Rajput, MD/PhD at Charité - Universitätsmedizin Berlin, Department of Dermatology, Venerology and Allergology. The trial plans to enroll 60 participants.
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