Registry update — unassessed
Effects of Randomized Controlled Exercise and Nutritional Interventions on Muscle Mass, Volume, Fat Infiltration, and Clinical Outcomes in Patients With Malignant Melanoma Receiving Immunotherapy
Trial registry update: NOT_YET_RECRUITING. No results reported in the supplied registry record.
RCTN=40Minor significance
What this changes
The finding has not established an approved change to our evidence assessment.
Source date: Oct 7, 2026 · Discovered: Oct 7, 2026 · Assessed: — · Research update
What it does not prove
- The abstract does not state what the study actually found—only its design and intended measurements—so it is unknown whether the intervention had any effect on muscle mass, quality of life, treatment tolerance, or other outcomes
- With n=40 and no reported effect sizes, the study may be underpowered to detect clinically meaningful differences between groups
- The study design does not isolate the effects of exercise from nutritional support, so any observed benefit cannot be attributed to resistance training alone
Extracted from supplied source material; model confidence is not a measured probability of correctness.
Study details
- Design
- Rct
- Sample size
- 40
- Duration
- 6 months
- Population
- Adults with stage II to IV malignant melanoma who are starting treatment with immune checkpoint inhibitors
- Primary outcome
- Skeletal muscle mass and muscle quality preservation or improvement, as measured by changes in skeletal muscle mass and volume
- Effect size
- —
- Significance
- Not reported
- Journal
- Institute of Oncology Ljubljana
- Published
- Oct 7, 2026
Sources
Primary source
- Institute of Oncology Ljubljana ↗Clinical trial
Recorded source passages
Abstract or registry material supplied for assessment; source version 1. This is not a claim of full-text review.
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.
Assessment history
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