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

NCT07680452 | Recruiting

• 1 other identifier: MelaFit
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin Cancer)

Keywords

fasting; diet; fiber; high-fiber; melanoma; STF; short-term fasting; microbiome; checkpoint-inhibitor; checkpoint-inhibition; immunotherapy

Outcome Measures

Primary Outcomes (5)

• Study feasability, measured by adequacy and efficiency of recruitment strategies

  Number of participants recruited per month (at least 2 per month)

  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

  Adherence to the Intervention for intervention groups (at least 70% of the fasting cycles)

  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

  Patient acceptability of study assessments (number of completed study visits)

  Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

• Feasibility of the study procedures

  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)

  Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

• Feasibility of the intervention procedures

  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)

  Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

Secondary Outcomes (20)

• Adverse events

  After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

• Hospitalizations rate

  After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

• Dose Interruption or reduction

  After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

• Cumulative dose

  After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

• Treatment discontinuation

  After 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

Other Outcomes (12)

• Waist circumference

  Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

• Hip circumference

  Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

• Bioimpedance measurement

  Baseline, after 6 weeks, after 3 months, after 6 months, optional follow-ups at 12 and 18 months

Study Arms (3)

High-Fiber Diet

ACTIVE COMPARATOR

Behavioral: High-Fiber Diet

High-Fiber Diet and Short-Term Fasting

EXPERIMENTAL

Behavioral: High-Fiber Diet and Short-Term Fasting

Observational

NO INTERVENTION

Interventions

High-Fiber Diet BEHAVIORAL

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

High-Fiber Diet

High-Fiber Diet and Short-Term Fasting BEHAVIORAL

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.

High-Fiber Diet and Short-Term Fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• University Hospital Heidelberg: collaborator
• CHUM Microbiome Research Center Montréal: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Melanoma; Fasting; Intermittent Fasting

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Feeding Behavior; Behavior

Study Officials

• Anika Rajput, MD/PhD

  Charité - Universitätsmedizin Berlin, Department of Dermatology, Venerology and Allergology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anika Rajput, MD/PhD

CONTACT

004930450618599; melafit@charite.de

Thomas Eigentler, Prof. Dr.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/PhD, Department of Dermatology, Venereology and Allergology, Charité - Universitätsmedizin Berlin, Clinician Scientist

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: July 2, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): July 5, 2028
• Study Completion (Estimated): December 5, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)