An interventional study of Structured Resistance Exercise and Individualized Nutritional Support in Melanoma, sponsored by Institute of Oncology Ljubljana. Not yet recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Institute of Oncology Ljubljana · Not applicable, Interventional, and Supportive care
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.
MEL-FIT-IO is an umbrella randomized interventional study evaluating a six-month structured resistance exercise and individualized nutritional intervention in patients with malignant melanoma receiving immune checkpoint inhibitors.
Two prespecified doctoral substudies are embedded within the parent study and use the same participants, study groups, randomization, and assessment schedule. No separate randomization is performed for the substudies.
The ultrasound substudy, protocol ORI2026-5 (US-MUMELICI), evaluates the validity and longitudinal responsiveness of skeletal muscle ultrasound. Rectus femoris shear-wave velocity, muscle stiffness, echogenicity, and thigh muscle thickness are compared with magnetic resonance imaging, dual-energy X-ray absorptiometry, and bioelectrical impedance analysis at baseline, 3 months, and 6 months.
The myokine and metabolic substudy, protocol ORI2026-35 (MY-MEL-FIT-IO), evaluates changes in circulating myokines, systemic inflammatory and immune-cell markers, metabolic parameters, body composition, treatment tolerance, and patient-reported outcomes. Biomarker analyses are performed in the prespecified subgroup of participants with metastatic melanoma.
Treatment with immune checkpoint inhibitors is provided as part of routine clinical care and is not the investigational intervention.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 2,649 interventional studies indexed under Melanoma.
Browse Melanoma studies →Institute of Oncology Ljubljana is the lead sponsor of 81 studies on the registry; 26 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Structured Resistance Exercise · Behavioral: Individualized Nutritional Support
Participants will receive standard oncology care, including treatment with immune checkpoint inhibitors, without the additional structured exercise program or individualized nutritional intervention.
A 24-week supervised and progressive whole-body resistance exercise program performed three times per week under the guidance of trained exercise professionals. Each session will last approximately 60 minutes and will include resistance exercises targeting the major muscle groups of the upper and lower body. Exercise intensity will progressively increase from approximately 60% to 70% of one-repetition maximum. A deload week at approximately 60% of one-repetition maximum will be scheduled every fourth week. Training load will be adjusted using repeated one-repetition maximum assessments and the Borg Rating of Perceived Exertion Scale. Exercise will not be performed on the day before study assessments to avoid acute effects on the measurements.
Individualized nutritional assessment and counseling provided by a clinical dietitian in cooperation with a physician specializing in clinical nutrition. Energy requirements will be determined using indirect calorimetry. The nutritional strategy will target a daily protein intake of 1.5 to 2 g/kg of body weight and a daily fiber intake of 30 to 40 g. Participants will receive 30 g of whey protein to be consumed within one hour after each exercise session. Oral nutritional supplements and other appropriate nutritional therapy will be prescribed when clinically indicated, including in participants with inadequate intake, malnutrition, cachexia, or sarcopenia.
Change From Baseline in Thigh Skeletal Muscle Volume Assessed by Magnetic Resonance Imaging
Thigh skeletal muscle volume will be quantified using magnetic resonance imaging. The change from baseline to 6 months will be compared between the exercise and nutritional intervention group and the standard oncology care group.
Time frame: Baseline and 6 months
Change From Baseline in Skeletal Muscle Fat Infiltration Assessed by Magnetic Resonance Imaging
Skeletal muscle fat infiltration in the thigh will be quantified using magnetic resonance imaging. The change from baseline to 6 months will be compared between the two study groups.
Time frame: Baseline and 6 months
Number of Participants With Sarcopenia at 6 Months
Sarcopenia will be assessed based on study measurements of skeletal muscle mass and muscle function. The number and proportion of participants with sarcopenia at 6 months will be compared between the exercise and nutritional intervention group and the standard oncology care group, taking baseline sarcopenia status into account.
Time frame: Baseline and 6 months
Mean Change From Baseline in Resting Energy Expenditure Assessed by Indirect Calorimetry
Resting energy expenditure will be measured using indirect calorimetry. The mean change from baseline to 6 months will be compared between the exercise and nutritional intervention group and the standard oncology care group.
Time frame: Baseline and 6 months
Change From Baseline in Lean Body Mass Assessed by Dual-Energy X-Ray Absorptiometry
Lean body mass will be assessed using dual-energy X-ray absorptiometry. Changes from baseline at 3 months and 6 months will be compared between the exercise and nutritional intervention group and the standard oncology care group.
Time frame: Baseline, 3 months, and 6 months
Mean Change From Baseline in Total Body Fat Mass Assessed by Dual-Energy X-Ray Absorptiometry
Total body fat mass will be measured in kilograms using dual-energy X-ray absorptiometry. Mean changes from baseline at 3 months and 6 months will be compared between the exercise and nutritional intervention group and the standard oncology care group.
Time frame: Baseline, 3 months, and 6 months
Number of Participants With at Least One Immunotherapy Treatment Delay
The number and proportion of participants who experience at least one delay in scheduled immune checkpoint inhibitor treatment during the 6-month study period will be determined from clinical records and compared between the exercise and nutritional intervention group and the standard oncology care group.
Time frame: From baseline through 6 months
Number of Participants With Premature Discontinuation of Immune Checkpoint Inhibitor Treatment
The number and proportion of participants who discontinue immune checkpoint inhibitor treatment before the planned completion of treatment during the 6-month study period will be determined from clinical records and compared between the exercise and nutritional intervention group and the standard oncology care group.
Time frame: From baseline through 6 months
Number of Participants With Grade 3 or Higher Immune Checkpoint Inhibitor-Related Toxicity
The number and proportion of participants who experience at least one grade 3 or higher toxicity related to immune checkpoint inhibitor treatment during the 6-month study period will be determined from clinical records and compared between the exercise and nutritional intervention group and the standard oncology care group.
Time frame: From baseline through 6 months
Mean Change From Baseline in Phase Angle Assessed by Bioelectrical Impedance Analysis
Phase angle will be measured in degrees using bioelectrical impedance analysis as an indicator of cellular integrity and muscle quality. Mean changes from baseline at 3 months and 6 months will be compared between the exercise and nutritional intervention group and the standard oncology care group.
Time frame: Baseline, 3 months, and 6 months
Correlation Between Rectus Femoris Shear-Wave Velocity Assessed by 2D-SWE and Quadriceps Intramuscular Fat Fraction Assessed by MRI
Rectus femoris shear-wave velocity will be measured in meters per second (m/s) using two-dimensional shear-wave elastography (2D-SWE). Quadriceps intramuscular fat fraction will be assessed using chemical-shift magnetic resonance imaging (MRI) and reported as the MRI-derived intramuscular fat fraction. The relationship between the two measurements will be evaluated using Pearson's or Spearman's correlation coefficient, as appropriate according to the distribution of the data. The correlation coefficient is unitless and ranges from -1 to 1.
Time frame: Baseline
Correlation Between Rectus Femoris Echogenicity Assessed by B-Mode Ultrasound and Quadriceps Intramuscular Fat Fraction Assessed by MRI
Rectus femoris echogenicity will be assessed from standardized B-mode ultrasound images as mean pixel intensity within a defined region of interest. At least three measurements will be averaged for the final value. Quadriceps intramuscular fat fraction will be assessed using chemical-shift magnetic resonance imaging (MRI) and reported as the MRI-derived intramuscular fat fraction. The relationship between the two measurements will be evaluated using Pearson's or Spearman's correlation coefficient, as appropriate according to the distribution of the data. The correlation coefficient is unitless and ranges from -1 to 1.
Time frame: Baseline
Change From Baseline in Thigh Muscle Thickness Assessed by Ultrasound
The thickness of the rectus femoris and vastus intermedius muscles will be assessed using ultrasound. Changes from baseline at 3 months and 6 months will be evaluated and compared with measures of lean mass obtained using dual-energy X-ray absorptiometry.
Time frame: Baseline, 3 months, and 6 months
Change From Baseline in Peripheral Blood NK and T-Lymphocyte Proportions
The proportions of natural killer cells and T lymphocytes in peripheral blood will be assessed. Changes from baseline will be compared between the two study groups in the metastatic melanoma substudy population.
Time frame: Baseline, 3 months, and 6 months
Change From Baseline in Circulating Myokine Concentrations
Circulating concentrations of selected myokines, including IL-6, IL-15, irisin/FNDC5, SPARC, and OSM, will be measured in peripheral blood. Changes from baseline will be compared between the exercise and nutritional intervention group and the standard oncology care group in the metastatic melanoma substudy population.
Time frame: Baseline, 3 months, and 6 months
Plan to share: No
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Institute of Oncology Ljubljana