Non Small Cell Lung CancerNCT01943578
Value of Physical Capacity Tests in Lung Cancer
An observational study of Non Small Cell Lung Cancer and Small Cell Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study examines the physical capacity of lung cancer patients assessed with the six minute walk test and handgrip strength. Demographic and selfreported exercise behavior is registered to explore correlations to functional and physical capacity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Small Cell Lung Cancer
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non Small Cell Lung Cancer Stage Small Cell Lung Cancer
Who may be able to join
- Non small cell lung cancer stage I-IV
- Small cell lung cancer
- Patients >18 years
- WHO performance status 0-2
- undergoing chemotherapy
Who cannot join
- unstable angina during the previous month
- myocardial infarction diagnosed within the last month
- not approval for physical activity by primary oncologist
- inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Cohort Study of the Value of the Six Minute Walk Test and Handgrip Strength in Lung Cancer Patients Undergoing Chemotherapy
The study examines the physical capacity of lung cancer patients assessed with the six minute walk test and handgrip strength. Demographic and selfreported exercise behavior is registered to explore correlations to functional and physical capacity.
Assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an expected average of 12 weeks between first and second assessment.
- Conditions
- Non Small Cell Lung Cancer, Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
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 patients | Non Small Cell Lung Cancer, Small Cell Lung Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality - Survival time
Prognostic value of the six minute walk and handgrip strength on mortality
Measured: time from first chemotherapy treatment to death, assessed after 30 months
Secondary outcomes (3)
Hand grip strength
Measured: before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
Self reported exercise behavior
Measured: before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
Six minute walk test
Measured: Before first and after fourth chemotheraphy cycle, an expected average of 12 weeks between first and second assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Quist, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Seppo Langer, Phd., Study chair, University Hospital of Copenhagen, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943578
- Sponsor's protocol ID
- 2007-58-0015-30-1059
- Status last verified
- Nov 2014
- First submitted
- 30 Aug 2013
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Study of the Value of the Six Minute Walk Test and Handgrip Strength in Lung Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT01943578
- Acronym / sponsor ID
- 2007-58-0015-30-1059
- Conditions
- Non Small Cell Lung Cancer, Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Sep 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.
The study examines the physical capacity of lung cancer patients assessed with the six minute walk test and handgrip strength. Demographic and selfreported exercise behavior is registered to explore correlations to functional and physical capacity.
Assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an expected average of 12 weeks between first and second assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer patients | – | –Non Small Cell Lung Cancer, Small Cell Lung Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non Small Cell Lung Cancer Stage Small Cell Lung Cancer
Key inclusion criteria (5 listed)
- Non small cell lung cancer stage I-IV
- Small cell lung cancer
- Patients >18 years
- WHO performance status 0-2
- undergoing chemotherapy
Key exclusion criteria (4 listed)
- unstable angina during the previous month
- myocardial infarction diagnosed within the last month
- not approval for physical activity by primary oncologist
- inability to provide informed consent.
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
Mortality - Survival time
Time frame: time from first chemotherapy treatment to death, assessed after 30 months
Prognostic value of the six minute walk and handgrip strength on mortality
3 secondary outcomes
Hand grip strength
Time frame: before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
Self reported exercise behavior
Time frame: before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
Six minute walk test
Time frame: Before first and after fourth chemotheraphy cycle, an expected average of 12 weeks between first and second assessment.
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 5 Nov 2014.
- Related InfoLink provided by the sponsor.
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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.
Seppo Langer, Phd. study chair
University Hospital of Copenhagen, Rigshospitalet
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 and Small Cell Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 inclusion and 4 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 5 Nov 2014. 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 Denmark. 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?
Mortality - Survival time (time frame: time from first chemotherapy treatment to death, assessed after 30 months). 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 5 Nov 2014.