About this trial
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.
Eligibility criteria
Qualifiers
Age: more than 18 years
Confirmed malignant neoplasm diagnosis
Hospitalization anticipated for at least 4 days
Capacity to provide informed consent and complete questionnaires
Disqualifiers
Medical contraindications to strength testing (recent fractures, acute injuries) - Severe neurological impairment precluding functional assessment
Implanted electronic devices (relative contraindication for bioimpedance)
Severe cognitive impairment preventing questionnaire completion
Extensive skin lesions preventing electrode placement for sEMG
Trial design
Treatments tested in this trial
- Screenig Phase