Health Trials

Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy

ConditionMelanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Structured Resistance Exercise

    Behavioral

    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 Support

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Exercise and Nutritional InterventionExperimental treatment 2 interventions
Group B: Standard Oncology CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

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
3

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
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Oncology Ljubljana

Lead sponsor

Science and Research Centre Koper

Collaborator

Source ClinicalTrials.gov
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