High-fiber diet with short-term fasting during melanoma immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the feasibility of pairing a high-fiber diet with short-term fasting in patients with stage IIB–IIIC melanoma who are receiving immune checkpoint inhibitor therapy. Participants will follow a high-fiber eating plan, with an option to add short-term fasting, to see if gut bacteria changes and tolerability of immunotherapy improve. The trial will monitor safety, adherence, and preliminary signals of treatment effect in a real-world clinical setting. Eligibility includes adults with good performance status and no recent systemic melanoma therapy. Enrollment is limited to centers affiliated with Charité Berlin and collaborating institutions.

Why it matters

Who can join: the full rules

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

Where it's running

• Charité - Universitätsmedizin Berlin
  Berlin, State of Berlin, Germany Recruiting

Study contacts

• Principal investigator: Anika Rajput, MD/PhD — Charité - Universitätsmedizin Berlin, Department of Dermatology, Venerology and Allergology
• Study coordinator: Anika Rajput, MD/PhD
• Email: melafit@charite.de
• Phone: 004930450618599

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.