COPDNCT02121379
Randomized Clinical Trial of 8 Weeks Pulmonary Rehabilitation in Advanced Stage Lung Cancer Patients With COPD During Cytotoxic Chemotherapy
A study testing pulmonary rehabilitation in people with COPD and Lung Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Pulmonary rehabilitation might be benificial in advanced lung cancer patients with COPD who undergo cytotoxic chemotherapy. We will compare two groups, 8 week pulmonary rehabilitation group and usual care group. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- COPD, Lung Cancer
- What is being tested?
- pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Oct 2015
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically proven lung cancer
- chronic obstructive pulmonary disease
- age > 20
- ECOG 0-1
- cytotoxic chemotherapy
Who cannot join
- other history of cancer within 5 years
- other major disease associated with heart, lung, neurology, mental and metabolic disorders
- osteolytic bone metastatis to weight bearing site
- uncontrolled infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Young Sik Park, Dr, 82-2-2072-7214, mdyspark@gmail.com
About this study
Pulmonary rehabilitation might be benificial in advanced lung cancer patients with COPD who undergo cytotoxic chemotherapy.
We will compare two groups, 8 week pulmonary rehabilitation group and usual care group.
- Conditions
- COPD, Lung Cancer
- Being tested
- pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | stretching exercise |
| pulmonary rehablitation | Experimental | warming up exercise strengthening exercise aerobic exercise cool down Receives: Behavioral: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of VO2 max
difference maximal oxygen consumption during exercise cardiopulmonary test between before and after intervention/control
Measured: 8 weeks
Secondary outcomes (4)
difference of Saint George's Respiratory Questionannaire (SGRQ) score
the difference of SGRQ score
Measured: 8 weeks
difference of pulmonary function test
the difference of FVC and FEV1
Measured: 8 weeks
difference of 6 min walk test
the difference of 6 minute walk test
Measured: 8 weeks
difference of depression test
using Hospital Anxiety and Depression scale (HADS), measure the difference HADS between before and after intervention/control
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Sik Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121379
- Sponsor's protocol ID
- H-1401-116-549
- Status last verified
- May 2014
- First submitted
- 18 Apr 2014
- Last updated
- 2 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of 8 Weeks Pulmonary Rehabilitation in Advanced Stage Lung Cancer Patients With COPD During Cytotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT02121379
- Acronym / sponsor ID
- H-1401-116-549
- Conditions
- COPD, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 23 Apr 2014 (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.
Pulmonary rehabilitation might be benificial in advanced lung cancer patients with COPD who undergo cytotoxic chemotherapy.
We will compare two groups, 8 week pulmonary rehabilitation group and usual care group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –stretching exercise |
| pulmonary rehablitation | Experimental | Behavioral: pulmonary rehabilitationwarming up exercise strengthening exercise aerobic exercise cool down |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pathologically proven lung cancer
- chronic obstructive pulmonary disease
- age > 20
- ECOG 0-1
- cytotoxic chemotherapy
Key exclusion criteria (4 listed)
- other history of cancer within 5 years
- other major disease associated with heart, lung, neurology, mental and metabolic disorders
- osteolytic bone metastatis to weight bearing site
- uncontrolled infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary rehabilitation | Behavioural | pulmonary rehablitation |
Primary outcome
difference of VO2 max
Time frame: 8 weeks
difference maximal oxygen consumption during exercise cardiopulmonary test between before and after intervention/control
4 secondary outcomes
difference of Saint George's Respiratory Questionannaire (SGRQ) score
Time frame: 8 weeks
difference of pulmonary function test
Time frame: 8 weeks
difference of 6 min walk test
Time frame: 8 weeks
difference of depression test
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation in people with COPD and Lung Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 2 Jun 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 South Korea. 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?
Contact Young Sik Park, Dr (82-2-2072-7214, mdyspark@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference of VO2 max (time frame: 8 weeks). 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 2 Jun 2014.