Menu
Not yet recruiting NCT07387770

Muscle Deterioration in Hospitalized Cancer Patient

No phase Interventional Oncologic Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Screenig Phase.
Who it may be relevant to
Registry conditions: Oncologic Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 ef

Primary outcome measures

  • SARC-F Sarcopenia Screening Tool [Time frame: Baseline and up to 10 days]
  • Symptoms prevalence. Memorial Symptom Assessment Scale (MSAS) [Time frame: Baseline and and up to 10 days]
  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [Time frame: Baseline and and up to 10 days]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and up to 10 days]
  • Bioimpedance Electrical Analysis [Time frame: Baseline and and up to 10 days]
  • Handgrip Strength Assessment [Time frame: Baseline and through study completion, an average of 10 days]
  • Surface Electromyography Assessment [Time frame: Baseline and through study completion, an average of 10 days]
Secondary outcome measures (1)
  • Blood sample collection [Time frame: Baseline and up to 10 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07387770 · ONCO2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗