Clinical trial · Observational
Cachexia in NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional and Skeletal Muscle Implications
Cachexia in Advanced NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional Implications and Validation of Skeletal Muscle Disfunction Markers
NCT03960034CI-TRIAL-00057861LUCAX01completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
LUCAX01 is a cohort study with patients with advanced NSCLC in tobacco users. in this study, patients will be submitted to baseline physical tests, blood and biopsy sample collection, and the main objective is to study the functional and prognostic implications of cachexia and to validate skeletal muscle dysfunction markers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival in cachectic and non-cachectic patient
- timeFrame
- 2 year
- description
- Survival will be measured to understand the prognostic impact of cancer cachexia in NSCLC patients.
Secondary outcomes (6)
- measure
- Physical fitness and response to treatment
- timeFrame
- 1 year
- description
- Response Evaluation in solid tumors (RECIST 1.1) will be used to evaluate the relationship between physical fitness and response to chemotherapy.
- measure
- Physical fitness and toxicity
- timeFrame
- 1 year
- description
- Common terminology criteria for adverse events (CTCAE 5.0) will be used to evaluate the relationship between physical fitness and toxicities related to chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced stage IVa or IVb NSCLC patients histologically diagnosis. * Eastern Cooperative Oncology Group Performance status 0 - 2 * Treatment-naive * Current smokers or ex-smokers * Normal renal, hepatic and hematological functions * Able to perform the physical functional tests * Able to read and sign the consent form Exclusion Criteria: * Initiate treatment before initiate * Diagnostic of tumor mutation ( epidermal growth factor receptor, Anaplastic lymphoma kinase) Obs: A smoker population with no known cancer will be used as controls (n=10)
References
Publications (0)
Data not yet available
No reference posted for this study.