Lung Neoplasm MalignantNCT05414188
Beneficial Effect of Pulmonary Rehabilitation in Lung Cancer Patients Receiving Radiation Therapy
A study testing Pulmonary rehabilitation in people with Lung Neoplasm Malignant, run by Asan Medical Center at 1 site in South Korea.
Trial summary
It is important for clinicians to maintain and support for exercise capacity and quality of life of lung cancer patients after radiation therapy, because radiation therapy also affect the lung function and general conditions of patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Neoplasm Malignant
- 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
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jun 2022to 31 Dec 2023
- 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
- Lung cancer patients with scheduled radiation therapy (postoperative adjuvant radiation therapy and concurrent chemoradiation therapy) during more than 4 weeks (5 times a week, 20 times a week)
- Lung parenchymal cancer
- Consent to regular outpatient-based pulmonary rehabilitation program, considering residence and other factors.
Who cannot join
- Communication restrictions
- Failed to obtain consent form
- Accompanied by psychiatric problems or severe dizziness
- Patients have comorbidities, which are regarded as contraindications of pulmonary rehabilitation, such as severe pulmonary hypertension or hemodynamic instability
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Songpa, 05505
About this study
Official title: The Improvement of the Quality of Life and Exercise Capacity Through Pulmonary Rehabilitation in Lung Cancer Patients Receiving Radiation Therapy
It is important for clinicians to maintain and support for exercise capacity and quality of life of lung cancer patients after radiation therapy, because radiation therapy also affect the lung function and general conditions of patients. The effect and safety of pulmonary rehabilitation is well-proven in various diseases. Because there is no standard treatment, the investigators will perform this study to clearly prove the effect of pulmonary rehabilitation in lung cancer patients receiving radiation therapy.
Read the detailed description
Roles of the radiation therapy in lung cancer are as followings; 1) to treat the lung caner stage 1 ~2 patients, who are inadequate for operation due to declined lung function, 2) to treat the locally advanced and inoperable stage 3 patients with concurrent chemotherapy, and 3) to palliatively treat the stage 4 patient. However, it is also possible that radiation therapy worsens the general weakness and lung function, although the degree of deterioration was generally less than lung resection. Therefore, it is crucial for clinicians to maintain and support for exercise capacity and quality of life of lung cancer patients after radiation therapy.
The effect and safety of pulmonary rehabilitation is well-proven in various diseases. Investigators presented a retrospective study about the effect of pulmonary rehabilitation in patients receiving radiation therapy, which showed less decreased lung function, less radiation related pneumonitis, and decreased mortality. Investigators will perform this study to clearly prove the effect of pulmonary rehabilitation in lung cancer patients receiving radiation therapy.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- Pulmonary rehabilitation
- Keywords
- Pulmonary rehabilitation, Radiation therapy, Lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationBehavioural
Pulmonary rehabilitation runs for 60 minutes per session. The pulmonary rehabilitation program is based on a comprehensive approach, not simply providing regular exercise. And it includes patient education, active encouragement, and psychological support by investigators. Exercise is performed more than twice a week. Each session is performed for 60 minutes and includes breathing exercises, low to medium-intensity aerobic exercises, and muscle exercises under the guidance of a investigator. After radiation therapy is completed, investigators will recommend that patients perform pulmonary rehabilitation at home more than twice a week and for 60 minutes or more. The patients will record whether and when exercise is performed every day in the diary for pulmonary rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation group | Active comparator | Patients will receive the radiation therapy according to the existing schedule. Additionally, patients in pulmonary rehabilitation group will participate pulmonary rehabilitation program more than two times per week. Receives: Behavioral: Pulmonary rehabilitation |
| Control group | No intervention | Patients will receive the radiation therapy according to the existing schedule. There will be no additional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 6 minutes walking test at 7 months
Change of walking distance from baseline 6 minutes walking test at 7 months
Measured: 7 months
Secondary outcomes (25)
All cause mortality
All cause mortality during study periods
Measured: From the initiation of radiation therapy to 7 months at end of radiation therapy
Radiation therapy related pneumonitis
Radiation therapy related pneumonitis requiring steroid therapy
Measured: From the initiation of radiation therapy to 7 months at end of radiation therapy
Forced Expiratory Volume in 1 sec at 7 months
Forced Expiratory Volume in 1 sec (L, predicted percentage) at 7 months
Measured: 7 months
Forced Expiratory Volume in 1 sec at 1 month
Forced Expiratory Volume in 1 sec (L, predicted percentage) at 1 month
Measured: 1 month
Forced Vital Capacity at 7 months
Forced Vital Capacity (L, predicted percentage) at 7 months
Measured: 7 months
Forced Vital Capacity at 1 month
Forced Vital Capacity (L, predicted percentage) at 1 month
Measured: 1 month
Carbon monoxide diffusing capacity at 7 months
Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 7 months
Measured: 7 months
Carbon monoxide diffusing capacity at 1 month
Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 1 month
Measured: 1 month
Change of dyspnea scale at 7 months
Investigators will measure the change from the baseline Modified Medical Research Council Dyspnea Scale in the range of 0 to 4, which means the higher the result, the more severe the degree of dyspnea
Measured: 7 months
Change of dyspnea scale at 1 month
Investigators will measure the change from the baseline Modified Medical Research Council Dyspnea Scale in the range of 0 to 4, which means the higher the result, the more severe the degree of dyspnea
Measured: 1 month
Grip strength at 7 months
Grip strength will be measured by digital group hand dynamometer
Measured: 7 months
Grip strength at 1 month
Grip strength will be measured by digital group hand dynamometer
Measured: 1 month
Maximal inspiratory pressure at 7 months
To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry
Measured: 7 months
Maximal expiratory pressure at 7 months
To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry
Measured: 7 months
Maximal inspiratory pressure at 1 month
To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry
Measured: 1 month
Maximal expiratory pressure at 1 month
To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry
Measured: 1 month
Skeletal muscle mass at 7 months
Investigators will measure the skeletal muscle mass by bioimpedance
Measured: 7 months
Skeletal muscle mass at 1 month
Investigators will measure the skeletal muscle mass by bioimpedance
Measured: 1 month
Appendicular muscle mass at 1 month
Investigators will measure the appendicular muscle mass by bioimpedance
Measured: 1 month
Appendicular muscle mass at 7 months
Investigators will measure the appendicular muscle mass by bioimpedance
Measured: 7 months
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 7 months
Investigators will assess change from the baseline quality of life of patients by questionnaire (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13) at 7 months. (the higher values indicate a greater degree of symptoms, min.: 0, max.: 100)
Measured: 7 months
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 7 months
Investigators will assess change from the baseline quality of life of patients by questionnaire (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) at 7 months. (the higher values indicate a greater degree of symptoms, min.: 0, max.: 100)
Measured: 7 months
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 1 month
Investigators will assess change from the baseline quality of life of patients by questionnaire (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13) at 1 month. (the higher values indicate a greater degree of symptoms, min.: 0, max.: 100)
Measured: 1 month
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 1 month
Investigators will assess change from the baseline quality of life of patients by questionnaire (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) at 1 month. (the higher values indicate a greater degree of symptoms, min.: 0, max.: 100)
Measured: 1 month
Change of 6 minutes walking test at 1 month
Change of walking distance from baseline 6 minutes walking test at 1 month
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start14 Jun 2022 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sei Won Lee, Asan Medical Center
- Investigators
- Jang Ho Lee, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414188
- Sponsor's protocol ID
- 2022-0483
- Status last verified
- Jun 2022
- First submitted
- 30 May 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study will be available from the primary investigator on reasonable request after end of the study.
Publications
Lee JH, Cha S, Ko EJ, Kim W, Kim SS, Song SY, Jeon JY, Ji W, Choi CM, Lee SH, Lee SW. Clinical effect of pulmonary rehabilitation during radiotherapy in lung cancer: A randomized controlled trial. Lung Cancer. 2025 Jun;204:108546. doi: 10.1016/j.lungcan.2025.108546. Epub 2025 Apr 17.
PubMed 40306134
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement of the Quality of Life and Exercise Capacity Through Pulmonary Rehabilitation in Lung Cancer Patients Receiving Radiation Therapy
- ClinicalTrials.gov ID
- NCT05414188
- Acronym / sponsor ID
- 2022-0483
- Conditions
- Lung Neoplasm Malignant
- Keywords
- Pulmonary rehabilitation, Radiation therapy, Lung cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 14 Jun 2022 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Jun 2022 (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.
It is important for clinicians to maintain and support for exercise capacity and quality of life of lung cancer patients after radiation therapy, because radiation therapy also affect the lung function and general conditions of patients. The effect and safety of pulmonary rehabilitation is well-proven in various diseases. Because there is no standard treatment, the investigators will perform this study to clearly prove the effect of pulmonary rehabilitation in lung cancer patients receiving radiation therapy.
Detailed description
Roles of the radiation therapy in lung cancer are as followings; 1) to treat the lung caner stage 1 ~2 patients, who are inadequate for operation due to declined lung function, 2) to treat the locally advanced and inoperable stage 3 patients with concurrent chemotherapy, and 3) to palliatively treat the stage 4 patient. However, it is also possible that radiation therapy worsens the general weakness and lung function, although the degree of deterioration was generally less than lung resection. Therefore, it is crucial for clinicians to maintain and support for exercise capacity and quality of life of lung cancer patients after radiation therapy.
The effect and safety of pulmonary rehabilitation is well-proven in various diseases. Investigators presented a retrospective study about the effect of pulmonary rehabilitation in patients receiving radiation therapy, which showed less decreased lung function, less radiation related pneumonitis, and decreased mortality. Investigators will perform this study to clearly prove the effect of pulmonary rehabilitation in lung cancer patients receiving radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation group | Active comparator | Behavioral: Pulmonary rehabilitationPatients will receive the radiation therapy according to the existing schedule. Additionally, patients in pulmonary rehabilitation group will participate pulmonary rehabilitation program more than two times per week. |
| Control group | No intervention | –Patients will receive the radiation therapy according to the existing schedule. There will be no additional treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lung cancer patients with scheduled radiation therapy (postoperative adjuvant radiation therapy and concurrent chemoradiation therapy) during more than 4 weeks (5 times a week, 20 times a week)
- Lung parenchymal cancer
- Consent to regular outpatient-based pulmonary rehabilitation program, considering residence and other factors.
Key exclusion criteria (4 listed)
- Communication restrictions
- Failed to obtain consent form
- Accompanied by psychiatric problems or severe dizziness
- Patients have comorbidities, which are regarded as contraindications of pulmonary rehabilitation, such as severe pulmonary hypertension or hemodynamic instability
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 rehabilitationPulmonary rehabilitation runs for 60 minutes per session. The pulmonary rehabilitation program is based on a comprehensive approach, not simply providing regular exercise. And it includes patient education, active encouragement, and psychological support by investigators. Exercise is performed more than twice a week. Each session is performed for 60 minutes and includes breathing exercises, low to medium-intensity aerobic exercises, and muscle exercises under the guidance of a investigator. After radiation therapy is completed, investigators will recommend that patients perform pulmonary rehabilitation at home more than twice a week and for 60 minutes or more. The patients will record whether and when exercise is performed every day in the diary for pulmonary rehabilitation. | Behavioural | Pulmonary rehabilitation group |
Primary outcome
Change of 6 minutes walking test at 7 months
Time frame: 7 months
Change of walking distance from baseline 6 minutes walking test at 7 months
25 secondary outcomes
All cause mortality
Time frame: From the initiation of radiation therapy to 7 months at end of radiation therapy
Radiation therapy related pneumonitis
Time frame: From the initiation of radiation therapy to 7 months at end of radiation therapy
Forced Expiratory Volume in 1 sec at 7 months
Time frame: 7 months
Forced Expiratory Volume in 1 sec at 1 month
Time frame: 1 month
Forced Vital Capacity at 7 months
Time frame: 7 months
Forced Vital Capacity at 1 month
Time frame: 1 month
Carbon monoxide diffusing capacity at 7 months
Time frame: 7 months
Carbon monoxide diffusing capacity at 1 month
Time frame: 1 month
Change of dyspnea scale at 7 months
Time frame: 7 months
Change of dyspnea scale at 1 month
Time frame: 1 month
Grip strength at 7 months
Time frame: 7 months
Grip strength at 1 month
Time frame: 1 month
Maximal inspiratory pressure at 7 months
Time frame: 7 months
Maximal expiratory pressure at 7 months
Time frame: 7 months
Maximal inspiratory pressure at 1 month
Time frame: 1 month
Maximal expiratory pressure at 1 month
Time frame: 1 month
Skeletal muscle mass at 7 months
Time frame: 7 months
Skeletal muscle mass at 1 month
Time frame: 1 month
Appendicular muscle mass at 1 month
Time frame: 1 month
Appendicular muscle mass at 7 months
Time frame: 7 months
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 7 months
Time frame: 7 months
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 7 months
Time frame: 7 months
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 1 month
Time frame: 1 month
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 1 month
Time frame: 1 month
Change of 6 minutes walking test at 1 month
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Derived from this study: PubMed 40306134Lee JH, Cha S, Ko EJ, Kim W, Kim SS, Song SY, Jeon JY, Ji W, Choi CM, Lee SH, Lee SW. Clinical effect of pulmonary rehabilitation during radiotherapy in lung cancer: A randomized controlled trial. Lung Cancer. 2025 Jun;204:108546. doi: 10.1016/j.lungcan.2025.108546. Epub 2025 Apr 17.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study will be available from the primary investigator on reasonable request after end of the study.
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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.
Jang Ho Lee, MD principal investigator
Asan Medical Center
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 Lung Neoplasm Malignant, run by Asan Medical Center 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 3 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 10 Jun 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 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 Sei Won Lee, MD, PhD (+82-2-3010-3990 ext. 3990, iseiwon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 6 minutes walking test at 7 months (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05414188, which also lists 1 linked publication.
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 10 Jun 2022.