MelanomaMEL-FIT-IONCT07761871
Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy
A study testing Structured Resistance Exercise and Individualized Nutritional Support in people with Melanoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Structured Resistance Exercise and Individualized Nutritional Support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- Dec 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
Institute of Oncology Ljubljana
Ljubljana, 1000
Nada Rotovnik Kozjek, MD, PhD, +38641 612 541, NKozjek@onko-i.si
Nada Rotovnik Kozjek
About this study
Official title: Effects of Randomized Controlled Exercise and Nutritional Interventions on Muscle Mass, Volume, Fat Infiltration, and Clinical Outcomes in Patients With Malignant Melanoma Receiving Immunotherapy
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Melanoma
- Being tested
- Structured Resistance Exercise, Individualized Nutritional Support
- Keywords
- Immune Checkpoint Inhibitors, Resistance Exercise, Nutritional Intervention, Skeletal Muscle Mass, Muscle Quality, Sarcopenia
- Medical subject headings
- Melanoma, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Resistance ExerciseBehavioural
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 SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Nutritional Intervention | Experimental | 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. Receives: Behavioral: Structured Resistance Exercise; Behavioral: Individualized Nutritional Support |
| Standard Oncology Care | No intervention | Participants will receive standard oncology care, including treatment with immune checkpoint inhibitors, without the additional structured exercise program or individualized nutritional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Science and Research Centre Koper
- Responsible party
- Sponsor
- Investigators
- Nada Rotovnik Kozjek, Principal investigator, Institute of Oncology Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761871
- Sponsor's protocol ID
- ORI2026-17
- Other IDs
- J7-70257, ARIS-RPROJ-Prijava-2025/632, ORI2026-5, ORI2026-35
- Acronym
- MEL-FIT-IO
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Randomized Controlled Exercise and Nutritional Interventions on Muscle Mass, Volume, Fat Infiltration, and Clinical Outcomes in Patients With Malignant Melanoma Receiving Immunotherapy
- ClinicalTrials.gov ID
- NCT07761871
- Acronym / sponsor ID
- MEL-FIT-IO / ORI2026-17
- Conditions
- Melanoma
- Keywords
- Immune Checkpoint Inhibitors, Resistance Exercise, Nutritional Intervention, Skeletal Muscle Mass, Muscle Quality, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Collaborators
- Science and Research Centre Koper
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and Nutritional Intervention | Experimental | Behavioral: Structured Resistance Exercise, Behavioral: Individualized Nutritional SupportParticipants 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. |
| Standard Oncology Care | No intervention | –Participants will receive standard oncology care, including treatment with immune checkpoint inhibitors, without the additional structured exercise program or individualized nutritional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Resistance ExerciseA 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. | Behavioural | Exercise and Nutritional Intervention |
| Individualized Nutritional SupportIndividualized 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. | Behavioural | Exercise and Nutritional Intervention |
Primary outcome
Change From Baseline in Thigh Skeletal Muscle Volume Assessed by Magnetic Resonance Imaging
Time frame: Baseline and 6 months
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.
Change From Baseline in Skeletal Muscle Fat Infiltration Assessed by Magnetic Resonance Imaging
Time frame: Baseline and 6 months
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.
Number of Participants With Sarcopenia at 6 Months
Time frame: Baseline and 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.
7 secondary outcomes
Mean Change From Baseline in Resting Energy Expenditure Assessed by Indirect Calorimetry
Time frame: Baseline and 6 months
Change From Baseline in Lean Body Mass Assessed by Dual-Energy X-Ray Absorptiometry
Time frame: Baseline, 3 months, and 6 months
Mean Change From Baseline in Total Body Fat Mass Assessed by Dual-Energy X-Ray Absorptiometry
Time frame: Baseline, 3 months, and 6 months
Number of Participants With at Least One Immunotherapy Treatment Delay
Time frame: From baseline through 6 months
Number of Participants With Premature Discontinuation of Immune Checkpoint Inhibitor Treatment
Time frame: From baseline through 6 months
Number of Participants With Grade 3 or Higher Immune Checkpoint Inhibitor-Related Toxicity
Time frame: From baseline through 6 months
Mean Change From Baseline in Phase Angle Assessed by Bioelectrical Impedance Analysis
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nada Rotovnik Kozjek principal investigator
Institute of Oncology Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Resistance Exercise and Individualized Nutritional Support in people with Melanoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nada Rotovnik Kozjek, MD, PhD (+38641 612 541, NKozjek@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Thigh Skeletal Muscle Volume Assessed by Magnetic Resonance Imaging (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.