Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy

NCT07761871 | Recruiting

• 5 other identifiers: ORI2026-17J7-70257ARIS-RPROJ-Prijava-2025/632ORI2026-5ORI2026-35
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Keywords

Immune Checkpoint Inhibitors; Resistance Exercise; Nutritional Intervention; Skeletal Muscle Mass; Muscle Quality; Sarcopenia

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and 6 months

Secondary Outcomes (7)

• Mean Change From Baseline in Resting Energy Expenditure Assessed by Indirect Calorimetry

  Baseline and 6 months

• Change From Baseline in Lean Body Mass Assessed by Dual-Energy X-Ray Absorptiometry

  Baseline, 3 months, and 6 months

• Mean Change From Baseline in Total Body Fat Mass Assessed by Dual-Energy X-Ray Absorptiometry

  Baseline, 3 months, and 6 months

• Number of Participants With at Least One Immunotherapy Treatment Delay

  From baseline through 6 months

• Number of Participants With Premature Discontinuation of Immune Checkpoint Inhibitor Treatment

  From baseline through 6 months

Other Outcomes (5)

• Correlation Between Rectus Femoris Shear-Wave Velocity Assessed by 2D-SWE and Quadriceps Intramuscular Fat Fraction Assessed by MRI

  Baseline

• Correlation Between Rectus Femoris Echogenicity Assessed by B-Mode Ultrasound and Quadriceps Intramuscular Fat Fraction Assessed by MRI

  Baseline

• Change From Baseline in Thigh Muscle Thickness Assessed by Ultrasound

  Baseline, 3 months, and 6 months

Study Arms (2)

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.

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.

Interventions

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.

Exercise and Nutritional Intervention

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.

Exercise and Nutritional Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead
• Science and Research Centre Koper: collaborator

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Melanoma; Sarcopenia

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Nada Rotovnik Kozjek

  Institute of Oncology Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nada Rotovnik Kozjek, MD, PhD

CONTACT

+38641 612 541; NKozjek@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)