Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy
Recruiting · NCT07761871 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Oncology Ljubljana
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Institute of Oncology Ljubljana - Ljubljana, Slovenia