Non-Small-cell Lung CancerNCT01885754
Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer
An observational study of Non-Small-cell Lung Cancer, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
Trial summary
Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Small-cell Lung Cancer
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Oct 2017
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with NSCLC
Who may be able to join
- Men and women with a primary lung cancer diagnosis
Who cannot join
- Already have undertaken surgery, chemotherapy or radiotherapy treatment
- Having an other cancer in the last five years
- Taking anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
Didier Saey, PhD, 418-656-8711 ext. 2614, didier.saey@criucpq.ulaval.ca
Didier Saey, PhD
About this study
Official title: Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer.
Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, its mechanisms ans its relation with muscle function and effort tolerance are still unknown.
Aim: To explore muscle function, signaling pathways and its relationship to impaired functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether they have cachexic state at diagnosis.
Read more
Methods: This study will be conducted at the Institut universitaire de cardiologie et de pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated whether or not they have a cachexic state. The evaluation will need two visits separated by 5 days.
During the evaluation the following tests will be done:
- Anthropometric measures
- Level of daily physical activity
- Pulmonary function test
- Maximal incremental cardiopulmonary exercise test on ergocycle
- Endurance test on ergocycle
- Muscle function tests
- Magnetic stimulation
- Quadriceps biopsy
- Conditions
- Non-Small-cell Lung Cancer
- Keywords
- Biopsy, Maximal incremental cardiopulmonary test, Muscle strength test, magnetic stimulation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer patient with cachexia | Muscle lumbar area < 55cm2/m2 for men and < 39 cm2/m2 for women | |
| Lung cancer patients without cachexia | Muscle lumbar area over 55cm2/m2 for men and 39 cm2/m2 for women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal quadriceps strength
Measured: 1 day (at the time of the diagnosis before any treatment)
Secondary outcomes (1)
Exercise capacity
Measured: 1 day (at the time of the diagnosis before any treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-cell Lung CancerStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Investigators
- Didier Saey, PhD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885754
- Sponsor's protocol ID
- 20878
- Status last verified
- Jan 2017
- First submitted
- 13 Feb 2013
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT01885754
- Acronym / sponsor ID
- 20878
- Conditions
- Non-Small-cell Lung Cancer
- Keywords
- Biopsy, Maximal incremental cardiopulmonary test, Muscle strength test, magnetic stimulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 25 Jun 2013 (estimated)
- 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.
Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, its mechanisms ans its relation with muscle function and effort tolerance are still unknown.
Aim: To explore muscle function, signaling pathways and its relationship to impaired functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether they have cachexic state at diagnosis.
Methods: This study will be conducted at the Institut universitaire de cardiologie et de pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated whether or not they have a cachexic state. The evaluation will need two visits separated by 5 days.
During the evaluation the following tests will be done:
- Anthropometric measures
- Level of daily physical activity
- Pulmonary function test
- Maximal incremental cardiopulmonary exercise test on ergocycle
- Endurance test on ergocycle
- Muscle function tests
- Magnetic stimulation
- Quadriceps biopsy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer patient with cachexia | – | –Muscle lumbar area < 55cm2/m2 for men and < 39 cm2/m2 for women |
| Lung cancer patients without cachexia | – | –Muscle lumbar area over 55cm2/m2 for men and 39 cm2/m2 for women |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NSCLC
Key inclusion criteria (1 listed)
- Men and women with a primary lung cancer diagnosis
Key exclusion criteria (3 listed)
- Already have undertaken surgery, chemotherapy or radiotherapy treatment
- Having an other cancer in the last five years
- Taking anticoagulation therapy
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
Maximal quadriceps strength
Time frame: 1 day (at the time of the diagnosis before any treatment)
1 secondary outcome
Exercise capacity
Time frame: 1 day (at the time of the diagnosis before any treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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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.
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Canada
Didier Saey, PhD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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 Non-Small-cell Lung Cancer, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal quadriceps strength (time frame: 1 day (at the time of the diagnosis before any treatment)). 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 6 Jan 2017.