NCT07761871Not yet recruiting
Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy
Effects of Randomized Controlled Exercise and Nutritional Interventions on Muscle Mass, Volume, Fat Infiltration, and Clinical Outcomes in Patients With Malignant Melanoma Receiving Immunotherapy
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
The purpose of this randomized study is to evaluate whether a six-month program of structured resistance exercise combined with individualized nutritional support can preserve or improve skeletal muscle mass and muscle quality in adults with stage II to IV malignant melanoma who are starting treatment with immune checkpoint inhibitors. Participants will be randomly assigned either to the exercise and nutritional intervention in addition to standard oncology care or to standard oncology care alone. The study aims to obtain complete measurements from at least 40 participants. Assessments will be performed at baseline, after 3 months, and after 6 months. They will include magnetic resonance imaging of the thigh, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, indirect calorimetry, clinical data, and patient-reported outcomes. The study will compare changes in skeletal muscle mass and volume, fatty infiltration of skeletal muscle, sarcopenia, body composition, resting energy expenditure, quality of life, fatigue, treatment tolerance, treatment delays, and early treatment discontinuation between the two groups. Treatment with immune checkpoint inhibitors is provided as part of routine clinical care and is not the investigational intervention.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 Jul 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Institute of Oncology Ljubljana
- Diseases
- Melanoma
- NCT number
- NCT07761871
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Dec 2026 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with immune checkpoint inhibitors or disease recurrence after previous treatment with immune checkpoint inhibitors.
- Contraindications to magnetic resonance imaging, such as MRI-incompatible metallic implants.
Other illness
- 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.
Other
- Symptomatic brain metastases.
- Participation in another study that includes structured physical exercise as part of its protocol.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.