Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potwierdzony czerniak stadium II, III lub IV
- •Planowane leczenie immunoterapią po raz pierwszy lub jako leczenie uzupełniające
- •Spodziewana długość życia dłuższa niż 6 miesięcy
- •Dobra znajomość języka słoweńskiego
- •Możliwość udzielenia pisemnej zgody i uczestnictwa w badaniu
✗ Disqualifies
- •Poprzednie leczenie immunoterapią lub powrót choroby po immunoterapii
- •Przerzuty do mózgu powodujące objawy
- •Przeciwwskazania do rezonansu magnetycznego, np. metalowe implanty
- •Choroby neurologiczne wpływające na mięśnie, np. dystrofia mięśniowa
- •Inne warunki uniemożliwiające bezpieczne uczestnictwo w badaniu
- •Jednoczesne uczestnictwo w innym badaniu obejmującym strukturalne ćwiczenia fizyczne
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 12, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Institute of Oncology Ljubljana
Ljubljana, Slovenia
Trial contact
Nada Rotovnik Kozjek, MD, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/13/2026.
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