NCT07387770

Muscle Deterioration in Hospitalized Cancer Patient

Assessment of Muscle Deterioration in Hospitalized Cancer Patients Using Surface Electromyography, Dynamometry, and Bioimpedance

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Salamanca · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cancer cachexia and skeletal muscle deterioration represent significant challenges in oncology, affecting up to 42% of cancer patients and correlating with poor clinical outcomes, increased treatment toxicity, and reduced overall survival. Early identification of patients at risk through comprehensive musculoskeletal assessment is essential for timely therapeutic intervention. This paper presents a detailed protocol for the longitudinal evaluation of skeletal muscle deterioration in hospitalized cancer patients using an integrated, multimodal approach. The protocol combines validated questionnaires (SARC-F, MSAS, EORTC QLQ-C30, and PSQI), functional measurements (handgrip strength), body composition analysis (bioelectrical impedance analysis), neuromuscular assessment (surface electromyography), and serum biomarkers (basic panel approach). The study aims to recruit 45-50 patients with confirmed malignancy requiring hospitalization for ≥4 days, with daily functional measurements and biomarker evaluations at admission and discharge. The protocol prioritizes methodological rigor in vulnerable populations, incorporates standardized procedures for real-world clinical settings, and emphasizes quality control measures. Expected outcomes include the identification of longitudinal patterns of muscle deterioration, validation of serum biomarker signatures for cachexia detection, and characterization of neuromuscular fatigue patterns using surface electromyography. This comprehensive framework addresses current gaps in skeletal muscle assessment during acute hospitalization and provides a foundation for future interventional studies. The protocol adheres to international ethical standards and considerations for research in vulnerable populations.

Conditions

• Oncologic Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Screenig Phase	EMG Parameters Analyzed: * Amplitude: Root mean square (RMS) during maximal voluntary contraction (MVC) and during sustained contraction, normalized to %MVC. * Frequency: Median frequency (MDF) and mean frequency (MNF) calculated using the fast Fourier transform (FFT) with 0.5-1 s sliding windows. Fatigue Indices * Rate of MDF decline (Hz/s) during sustained contraction. * Ratio of RMS at the end versus the beginning of the sustained contraction. * Time to task failure (s) during sustained effort. Quality Control: Quality control included real-time visual inspection of signals for movement artifacts, verification of baseline stability (resting activity \<10-20 µV RMS), and complete post-acquisition review with exclusion of segments containing \>20% artifact contamination.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2026-02-04
• Last updated: 2026-02-04