NCT07680452Recruiting
Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition
Exploratory Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 3 Jun 2026
- Start date
- 28 Jul 2026
- Primary completion date
- 5 Jul 2028
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Melanoma
- NCT number
- NCT07680452
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 28 Jul 2026 to the primary completion date, 5 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics within 4 weeks prior to the start of the study intervention
Other illness
- Pre-existing eating disorder
Lab values
- Severe internal medical conditions (e.g., renal insufficiency with creatinine \> 2 mg/dL) or secondary malignancy
Other
- Pregnancy or breastfeeding
- Underweight (BMI ≤19.5)
- Current vegan diet or prolonged fasting (≤ 4 days) within the last 6 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.