Muscle Deterioration in Hospitalized Cancer Patient
ConditionOncologic Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Salamanca
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Screenig Phase
Diagnostic testEMG 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: EMGExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
SARC-F Sarcopenia Screening Tool
The SARC-F questionnaire (Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls) will be administered to all participants at baseline and at discharge. This five-item instrument evaluates functional limitations, with total scores ranging from 0 to 10; scores ≥4 indicate an increased risk of sarcopenia. The SARC-F demonstrates a sensitivity of 71-89% and a specificity of 84-91% for sarcopenia detection across diverse populations.
Time frame
Baseline and up to 10 days2
Symptoms prevalence. Memorial Symptom Assessment Scale (MSAS)
The Memorial Symptom Assessment Scale (MSAS) will be administered using the validated Spanish version by Llamas-Ramos et al. The 24-item short form (MSAS-SF) assesses symptom frequency, severity, and associated distress across three core dimensions: the Global Distress Index, the Physical Symptom Subscale, and the Psychological Symptom Subscale. The instrument has demonstrated excellent psychometric properties in Spanish-speaking cancer populations (Cronbach's α \> 0.80) and superior sensitivity to symptom changes compared with single-item scales.
Time frame
Baseline and and up to 10 days3
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is the gold-standard instrument for assessing quality of life in cancer patients. This 30-item questionnaire evaluates five functional scales (physical, role, emotional, cognitive, and social functioning), global health status/quality of life, symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, and diarrhea), and financial difficulties. Scores are linearly transformed to 0-100 scales, with higher scores indicating better functioning on functional scales and greater symptom burden on symptom scales. The EORTC QLQ-C30 has demonstrated prognostic validity for survival outcomes across multiple cancer types.
Time frame
Baseline and and up to 10 days4
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) evaluates sleep quality over the preceding month using 19 self-reported items, yielding seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). The global PSQI score ranges from 0 to 21, with scores \>5 indicating poor sleep quality. Among cancer patients, the PSQI demonstrates 89.6% sensitivity and adequate psychometric properties for detecting sleep disturbances.
Time frame
Baseline and up to 10 daysSecondary outcomes
1
Blood sample collection
Blood samples will be collected during routine morning laboratory draws at admission and discharge, with additional volumes (10-15 mL) obtained for research purposes. Serum will be separated via centrifugation at 3000 rpm for 10 minutes and stored at -80°C until batch analysis. All analytical procedures will be performed in accordance with standard hospital clinical laboratory protocols.
Time frame
Baseline and up to 10 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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