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Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy
Sponsor: Institute of Oncology Ljubljana
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-12
Completion Date
2029-06
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Structured Resistance Exercise
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
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.
Locations (1)
Institute of Oncology Ljubljana
Ljubljana, Slovenia