Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized Nutritional Support | Behavioral | — | UNRESOLVED |
| Structured Resistance Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise and Nutritional Intervention
- description
- Participants will receive standard oncology care, including treatment with immune checkpoint inhibitors, together with a six-month structured resistance exercise program performed three times per week under the supervision of trained exercise professionals and individualized nutritional support.
- interventionNames
- Behavioral: Structured Resistance Exercise
- Behavioral: Individualized Nutritional Support
- type
- NO_INTERVENTION
- label
- Standard Oncology Care
- description
- Participants will receive standard oncology care, including treatment with immune checkpoint inhibitors, without the additional structured exercise program or individualized nutritional intervention.
Primary outcomes (3)
- measure
- Change From Baseline in Thigh Skeletal Muscle Volume Assessed by Magnetic Resonance Imaging
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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