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

Official title

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

Overview

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.

Interventions

• Behavioral High-Fiber Diet
  High-Fiber Diet (\>35g/day) according to the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) for 6 months.
• Behavioral 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.

Primary outcome measures

• Study feasability, measured by adequacy and efficiency of recruitment strategies [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Study feasability, measured by adherence to the intervention and dropout rate [Time frame: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Study feasability, measured by acceptability of study outcome measures [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Feasibility of the study procedures [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Feasibility of the intervention procedures [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]

Secondary outcome measures (12)

• Adverse events [Time frame: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Hospitalizations rate [Time frame: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Dose Interruption or reduction [Time frame: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Cumulative dose [Time frame: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Treatment discontinuation [Time frame: After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Subjective Severity of the main symptom [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Distress Thermometer [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Health status (EQ-5D-5L) [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Short Form 36 [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Quality of life of cancer patients (EORTC QLQ-C30) [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Nutrition [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]
• Differential blood count [Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Germany · 1 center

• Charité - Universitätsmedizin Berlin — Berlin

Identifiers

NCT: NCT07680452 · MelaFit

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗