Instituto do Câncer do Estado de São Paulo
São Paulo, 01246-000, Brazil
NCT Number: NCT03960034
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.
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Notify Me18 year–100 year
All sexes
Observational
São Paulo, 01246-000, Brazil
Non-small-cell lung cancer (NSCLC) is currently the neoplasm leading in deaths worldwide and in Brazil, it figures as the second most common cancer in terms of the number of deaths. Patients are usually diagnosed in advanced stages and, consequently, more than 45% of all patients are diagnosed with cachexia. This syndrome is characterized by a loss of muscle mass with or without fat loss and it cannot be reversed by nutritional support. In the physiopathology of cachexia, generally are present exacerbated inflammation, severe loss of muscle contractile proteins, leading to fatigue and increased mortality. Furthermore, patients with cachexia usually do present lower response rates to anticancer treatments and it is also associated with a worse overall prognosis.
Treatments directed to mitigate muscle loss in these patients are awaited. Cohort studies do suggest a significant positive impact of physical fitness and prognosis in different chronic diseases; however, its impact in advanced NSCLC patients is not clear. Here our aim is to better understand the relationship between cachexia and physical fitness variables (muscle and cardiorespiratory function, body composition, and daily physical activity level) with prognosis and mortality in a group of NSCLC patients, as well as to study the effect of chemotherapy on these variables. Besides that, will be evaluated the skeletal muscle, Treg lymphocytes, and inflammatory biomarkers and compare cachectic and non-cachectic patients.
Sixty NSCLC patients will be accrued. Will be assessed the maximum oxygen consumption, daily physical activity, muscle function, muscle morphology, anxiety, depression, performance status, and fatigue pre-treatment. Blood and muscle biopsy samples will be collected. The prognostic impact of these physical fitness variables will be defined, as well as their predictive value in terms of response to anticancer treatments in advanced NSCLC patients.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Obs: A smoker population with no known cancer will be used as controls (n=10)
Time frame: 2 year
Survival will be measured to understand the prognostic impact of cancer cachexia in NSCLC patients.
Time frame: 1 year
Response Evaluation in solid tumors (RECIST 1.1) will be used to evaluate the relationship between physical fitness and response to chemotherapy.
Time frame: 1 year
Common terminology criteria for adverse events (CTCAE 5.0) will be used to evaluate the relationship between physical fitness and toxicities related to chemotherapy.
Time frame: 1 year
Determination of down and up-regulated skeletal muscle pathways cachectic and non-cachectic patient using RNA-sec.
Time frame: 1 year
Determination of CD4+ profile in cachectic and non-cachectic patients using flow cytometry.
Time frame: 1 year
Determination of CD25+ profile in cachectic and non-cachectic patients using flow cytometry.
Time frame: 1 year
Determination of Fox-p3+ profile in cachectic and non-cachectic patients using flow cytometry.
Instituto do Cancer do Estado de São Paulo
Other
Cachexia in Advanced NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional Implications and Validation of Skeletal Muscle Disfunction Markers
Acronym: LUCAX01
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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