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Muscle Deterioration in Hospitalized Cancer Patient (MUSONC)

U

University of Salamanca

Status

Begins enrollment this month

Conditions

Oncologic Diseases

Treatments

Diagnostic Test: Screenig Phase

Study type

Interventional

Funder types

Other

Identifiers

NCT07387770
ONCO2026

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: more than 18 years
  • Confirmed malignant neoplasm diagnosis
  • Hospitalization anticipated for at least 4 days
  • Capacity to provide informed consent and complete questionnaires
  • ECOG performance status 0-3
  • Ability to perform voluntary contractions of upper and lower extremities

Exclusion criteria

  • 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

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

EMG
Experimental group
Description:
EMG screening
Treatment:
Diagnostic Test: Screenig Phase

Trial contacts and locations

0

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Central trial contact

Inés Dr. Llamas-Ramos

Data sourced from clinicaltrials.gov

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