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Could a Six-Month exercise and diet plan shield muscle during melanoma treatment?

NCT ID NCT07761871

Disease control Sponsor: Institute of Oncology Ljubljana 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether a six-month program of supervised resistance exercise and personalized nutritional support can help adults with stage II to IV melanoma preserve muscle mass and quality while starting immunotherapy. Participants are randomly assigned to either the exercise and nutrition program alongside standard cancer care, or standard care alone. The study tracks changes in thigh muscle volume, fat infiltration, body composition, fatigue, and treatment tolerance over six months. The goal is to see if this supportive approach can reduce muscle loss and improve outcomes during immunotherapy.

What this could mean

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

Active substance
Structured resistance exercise combined with individualized nutritional support
What this could lead to
If effective, this approach could help melanoma patients on immunotherapy maintain muscle mass and quality, potentially improving treatment tolerance and quality of life.
What could go wrong
This is a small early-stage trial, and results may not apply broadly. The intervention may not significantly change muscle outcomes or clinical results.

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 40 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

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: * Age 18 years or older. * Confirmed diagnosis of malignant melanoma, stage II, III, or IV. * Planned first-line or adjuvant treatment with immune checkpoint inhibitors. * Life expectancy greater than 6 months. * Sufficient knowledge of the Slovenian language. * Ability to provide written informed consent and comply with the study protocol. Exclusion Criteria: * Previous treatment with immune checkpoint inhibitors or disease recurrence after previous treatment with immune checkpoint inhibitors. * Symptomatic brain metastases. * Contraindications to magnetic resonance imaging, such as MRI-incompatible metallic implants. * Neurological diseases affecting the skeletal muscular system, such as muscular dystrophy. * Any condition that, in the investigator's judgment, prevents participation or the safe performance of study assessments. * Participation in another study that includes structured physical exercise as part of its protocol.

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Conditions

The condition(s) this trial relates to.

melanoma Sarcopenia

As listed by the trial registrant

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

Melanoma

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

  • Institute of Oncology Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

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