Cachexia in NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional and Skeletal Muscle Implications

NCT ID: NCT03960034

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2020-12-30

Brief Summary

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.

Detailed Description

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.

Conditions

NSCLC Stage IV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilberto de Castro Junior, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Câncer do Estado de São Paulo - FMUSP

Locations

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

NP802/15

Identifier Type: -

Identifier Source: org_study_id