Oncologic DiseasesMUSONCNCT07387770
Muscle Deterioration in Hospitalized Cancer Patient
A study testing Screenig Phase in people with Oncologic Diseases, run by University of Salamanca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Diseases
- What is being tested?
- Screenig Phase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007
Inés Llamas-Ramos, +34630720990, inesllamas@usal.es
About this study
Official title: Assessment of Muscle Deterioration in Hospitalized Cancer Patients Using Surface Electromyography, Dynamometry, and Bioimpedance
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).
Read more
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
- Being tested
- Screenig Phase
- Keywords
- cancer cachexia, sarcopenia, surface electromyography, bioimpedance analysis, hospitalized patients, protocol, muscle deterioration
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screenig PhaseDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| EMG | Experimental | EMG screening Receives: Diagnostic Test: Screenig Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 10 days
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.
Measured: Baseline and and up to 10 days
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.
Measured: Baseline and and up to 10 days
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.
Measured: Baseline and up to 10 days
Bioimpedance Electrical Analysis
Bioelectrical Impedance Analysis (BIA) will be performed using InBody equipment (bipedal configuration, 50 kHz impedance measurement). Standardized protocols will include: (1) 4-6 h of fasting, when feasible; (2) micturition 30 min prior to assessment; (3) a 15-min supine rest period to allow for fluid redistribution; and (4) documentation of hydration status using a structured clinical scale.
Measured: Baseline and and up to 10 days
Handgrip Strength Assessment
Handgrip strength will be measured daily using a calibrated digital dynamometer (EH101, China), following the American Society of Hand Therapists (ASHT) protocol. Prior to study initiation, the dynamometer underwent precision testing using calibrated weights (error <5%) and reliability assessment in 12 healthy volunteers (ICC = 0.92, 95% CI: 0.86-0.96).
Measured: Baseline and through study completion, an average of 10 days
Surface Electromyography Assessment
Surface electromyography (sEMG) will be acquired using the mDurance system (Shimmer3 wireless hardware), with a sampling rate of 1000 Hz, band-pass filtering from 10 to 500 Hz, and a 50 Hz notch filter to eliminate power-line interference.
Electrode Preparation and Placement Skin will be prepared by shaving with disposable razors, gentle abrasion with fine-grit sandpaper, and cleansing with 70% alcohol, followed by complete air-drying. Disposable Ag/AgCl electrodes (20 mm interelectrode distance, in accordance with SENIAM recommendations) will be placed using precise anatomical landmarks on the vastus lateralis, vastus medialis, and upper trapezius muscles.
Measured: Baseline and through study completion, an average of 10 days
Secondary 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.
Measured: Baseline and up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Jul 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inés Llamas-Ramos, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387770
- Sponsor's protocol ID
- ONCO2026
- Acronym
- MUSONC
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Muscle Deterioration in Hospitalized Cancer Patients Using Surface Electromyography, Dynamometry, and Bioimpedance
- ClinicalTrials.gov ID
- NCT07387770
- Acronym / sponsor ID
- MUSONC / ONCO2026
- Conditions
- Oncologic Diseases
- Keywords
- cancer cachexia, sarcopenia, surface electromyography, bioimpedance analysis, hospitalized patients, protocol, muscle deterioration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMG | Experimental | Diagnostic Test: Screenig PhaseEMG screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screenig PhaseEMG 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. | Diagnostic test | EMG |
Primary outcome
SARC-F Sarcopenia Screening Tool
Time frame: Baseline and up to 10 days
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.
Symptoms prevalence. Memorial Symptom Assessment Scale (MSAS)
Time frame: Baseline and and up to 10 days
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.
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
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.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and up to 10 days
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.
Bioimpedance Electrical Analysis
Time frame: Baseline and and up to 10 days
Bioelectrical Impedance Analysis (BIA) will be performed using InBody equipment (bipedal configuration, 50 kHz impedance measurement). Standardized protocols will include: (1) 4-6 h of fasting, when feasible; (2) micturition 30 min prior to assessment; (3) a 15-min supine rest period to allow for fluid redistribution; and (4) documentation of hydration status using a structured clinical scale.
Handgrip Strength Assessment
Time frame: Baseline and through study completion, an average of 10 days
Handgrip strength will be measured daily using a calibrated digital dynamometer (EH101, China), following the American Society of Hand Therapists (ASHT) protocol. Prior to study initiation, the dynamometer underwent precision testing using calibrated weights (error <5%) and reliability assessment in 12 healthy volunteers (ICC = 0.92, 95% CI: 0.86-0.96).
Surface Electromyography Assessment
Time frame: Baseline and through study completion, an average of 10 days
Surface electromyography (sEMG) will be acquired using the mDurance system (Shimmer3 wireless hardware), with a sampling rate of 1000 Hz, band-pass filtering from 10 to 500 Hz, and a 50 Hz notch filter to eliminate power-line interference. Electrode Preparation and Placement Skin will be prepared by shaving with disposable razors, gentle abrasion with fine-grit sandpaper, and cleansing with 70% alcohol, followed by complete air-drying. Disposable Ag/AgCl electrodes (20 mm interelectrode distance, in accordance with SENIAM recommendations) will be placed using precise anatomical landmarks on the vastus lateralis, vastus medialis, and upper trapezius muscles.
1 secondary outcome
Blood sample collection
Time frame: Baseline and up to 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screenig Phase in people with Oncologic Diseases, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inés Dr. Llamas-Ramos (+34630720990, inesllamas@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARC-F Sarcopenia Screening Tool (time frame: Baseline and up to 10 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.