Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy (NCT07761871) | Clinical Trial Compass
RecruitingNot Applicable
Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy
Slovenia40 participantsStarted 2026-08
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Thigh Skeletal Muscle Volume Assessed by Magnetic Resonance Imaging
Timeframe: Baseline and 6 months
2
Change From Baseline in Skeletal Muscle Fat Infiltration Assessed by Magnetic Resonance Imaging
Timeframe: Baseline and 6 months
3
Number of Participants With Sarcopenia at 6 Months