No phaseNot yet recruitingHealthspan endpoint
Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy (MEL-FIT-IO)
Effects of Randomized Controlled Exercise and Nutritional Interventions on Muscle Mass, Volume, Fat Infiltration, and Clinical Outcomes in Patients With Malignant Melanoma Receiving Immunotherapy
- Sponsor
- Institute of Oncology Ljubljana (Academic or other)
- Enrolment
- 40 planned
- Conditions
- Melanoma
- Interventions
- Structured Resistance Exercise; Individualized Nutritional Support
- Ages
- adults, older adults
- Registry
- NCT07761871
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Change From Baseline in Thigh Skeletal Muscle Volume Assessed by Magnetic Resonance Imaging
- Change From Baseline in Skeletal Muscle Fat Infiltration Assessed by Magnetic Resonance Imaging
- Number of Participants With Sarcopenia at 6 Months
History
Primary completion expected
Expected to start
Last registry update
Registered