NSCLC Stage IVLUCAX01NCT03960034
Cachexia in NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional and Skeletal Muscle Implications
An observational study of NSCLC Stage IV, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- NSCLC Stage IV
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Apr 2017to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
About this study
Official title: Cachexia in Advanced NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional Implications and Validation of Skeletal Muscle Disfunction Markers
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.
Read the 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
- Keywords
- Cachexia, Skeletal Muscle Atrophy, Physical Functional Performance, Prognosis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Cachexia, Muscular Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival in cachectic and non-cachectic patient
Survival will be measured to understand the prognostic impact of cancer cachexia in NSCLC patients.
Measured: 2 year
Secondary outcomes (6)
Physical fitness and response to treatment
Response Evaluation in solid tumors (RECIST 1.1) will be used to evaluate the relationship between physical fitness and response to chemotherapy.
Measured: 1 year
Physical fitness and toxicity
Common terminology criteria for adverse events (CTCAE 5.0) will be used to evaluate the relationship between physical fitness and toxicities related to chemotherapy.
Measured: 1 year
Cancer cachexia skeletal muscle pathways
Determination of down and up-regulated skeletal muscle pathways cachectic and non-cachectic patient using RNA-sec.
Measured: 1 year
Cluster of Differentiation 4+ (CD4+) population in cachectic and non-cachectic patient.
Determination of CD4+ profile in cachectic and non-cachectic patients using flow cytometry.
Measured: 1 year
Cluster of Differentiation 25+ (CD25+) population.
Determination of CD25+ profile in cachectic and non-cachectic patients using flow cytometry.
Measured: 1 year
Forkhead box P3 regulatory T (Fox-p3+) population.
Determination of Fox-p3+ profile in cachectic and non-cachectic patients using flow cytometry.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start10 Apr 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilberto de Castro Junior, MD, PhD, Principal investigator, Instituto do Câncer do Estado de São Paulo - FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960034
- Sponsor's protocol ID
- NP802/15
- Acronym
- LUCAX01
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cachexia in Advanced NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional Implications and Validation of Skeletal Muscle Disfunction Markers
- ClinicalTrials.gov ID
- NCT03960034
- Acronym / sponsor ID
- LUCAX01 / NP802/15
- Conditions
- NSCLC Stage IV
- Keywords
- Cachexia, Skeletal Muscle Atrophy, Physical Functional Performance, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 22 May 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Physical fitness and response to treatment
Time frame: 1 year
Physical fitness and toxicity
Time frame: 1 year
Cancer cachexia skeletal muscle pathways
Time frame: 1 year
Cluster of Differentiation 4+ (CD4+) population in cachectic and non-cachectic patient.
Time frame: 1 year
Cluster of Differentiation 25+ (CD25+) population.
Time frame: 1 year
Forkhead box P3 regulatory T (Fox-p3+) population.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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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. This study is not recruiting at the moment.
Gilberto de Castro Junior, MD, PhD principal investigator
Instituto do Câncer do Estado de São Paulo - FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC Stage IV, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 15 Apr 2022. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival in cachectic and non-cachectic patient (time frame: 2 year). 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 15 Apr 2022.