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Can diet boost immunotherapy? study tests High-Fiber and fasting in melanoma

NCT ID NCT07680452

Knowledge-focused Sponsor: Charite University, Berlin, Germany Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study looks at whether adding a high-fiber diet and short-term fasting can help melanoma patients undergoing immunotherapy. Forty participants will follow a high-fiber diet, with half also doing 72-hour fasts during each treatment cycle, while 20 others serve as a control group. The main goal is to see if this approach is feasible, with exploratory checks on quality of life, side effects, and immune system changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-fiber diet and short-term fasting
What this could lead to
If successful, this could pave the way for larger studies on dietary support to improve immunotherapy effectiveness and reduce side effects in melanoma.
What could go wrong
This is an early feasibility study with only 60 participants, so results may not be conclusive. Dietary interventions can be hard to follow, and the study may not show clear benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Fasting Intermittent Fasting melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma (skin cancer)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, State of Berlin, 10117, Germany

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