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Cachexia in NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional and Skeletal Muscle Implications (LUCAX01)

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ClinicalTrials.gov Identifier: NCT03960034
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

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.

Condition or disease
NSCLC Stage IV

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.


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Study Type : Observational
Estimated Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cachexia in Advanced NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional Implications and Validation of Skeletal Muscle Disfunction Markers
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : January 31, 2021



Primary Outcome Measures :
  1. Overall survival in cachectic and non-cachectic patient [ Time Frame: 2 year ]
    Survival will be measured to understand the prognostic impact of cancer cachexia in NSCLC patients.


Secondary Outcome Measures :
  1. Physical fitness and response to treatment [ 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.

  2. Physical fitness and toxicity [ 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.

  3. Cancer cachexia skeletal muscle pathways [ Time Frame: 1 year ]
    Determination of down and up-regulated skeletal muscle pathways cachectic and non-cachectic patient using RNA-sec.

  4. Cluster of Differentiation 4+ (CD4+) population in cachectic and non-cachectic patient. [ Time Frame: 1 year ]
    Determination of CD4+ profile in cachectic and non-cachectic patients using flow cytometry.

  5. Cluster of Differentiation 25+ (CD25+) population. [ Time Frame: 1 year ]
    Determination of CD25+ profile in cachectic and non-cachectic patients using flow cytometry.

  6. Forkhead box P3 regulatory T (Fox-p3+) population. [ Time Frame: 1 year ]
    Determination of Fox-p3+ profile in cachectic and non-cachectic patients using flow cytometry.


Biospecimen Retention:   Samples With DNA
Skeletal muscle from vastus lateralis and whole blood, blood plasma and peripheral blood mononuclear cells.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
NSCLC patient, current smokers or ex-smokers treatment naive with good Eastern Cooperative Oncology Group Performance status (ECOG-PS). A smoker population with no known cancer will be used as controls (n=10)
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960034


Contacts
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Contact: Willian Neves, MS +55 11 3896-2686 willian.dasneves@usp.br

Locations
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Brazil
Instituto do Câncer do Estado de São Paulo Recruiting
São Paulo, SP, Brazil, 01246-000
Contact: Gilberto de Castro Junior, MD, PhD    +55 11 3896-2686    gilberto.castro@usp.br   
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
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Principal Investigator: Gilberto de Castro Junior, MD, PhD Instituto do Câncer do Estado de São Paulo - FMUSP

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Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT03960034     History of Changes
Other Study ID Numbers: NP802/15
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto do Cancer do Estado de São Paulo:
Cachexia
Skeletal Muscle Atrophy
Physical Functional Performance
Prognosis
Additional relevant MeSH terms:
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Wasting Syndrome
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders