Clinical trial NCT05414188: Beneficial Effect of Pulmonary Rehabilitation in Lung Cancer Patients Receiving Radiation Therapy
Official title: The Improvement of the Quality of Life and Exercise Capacity Through Pulmonary Rehabilitation in Lung Cancer Patients Receiving Radiation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasm Malignant
Keywords: Pulmonary rehabilitation
Radiation therapy
Lung cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of 6 minutes walking test at 7 months
timeFrame: 7 months
Secondary outcomes:
measure: All cause mortality
timeFrame: From the initiation of radiation therapy to 7 months at end of radiation therapy
measure: Radiation therapy related pneumonitis
timeFrame: From the initiation of radiation therapy to 7 months at end of radiation therapy
measure: Forced Expiratory Volume in 1 sec at 7 months
timeFrame: 7 months
measure: Forced Expiratory Volume in 1 sec at 1 month
timeFrame: 1 month
measure: Forced Vital Capacity at 7 months
timeFrame: 7 months
measure: Forced Vital Capacity at 1 month
timeFrame: 1 month
measure: Carbon monoxide diffusing capacity at 7 months
timeFrame: 7 months
measure: Carbon monoxide diffusing capacity at 1 month
timeFrame: 1 month
measure: Change of dyspnea scale at 7 months
timeFrame: 7 months
measure: Change of dyspnea scale at 1 month
timeFrame: 1 month
measure: Grip strength at 7 months
timeFrame: 7 months
measure: Grip strength at 1 month
timeFrame: 1 month
measure: Maximal inspiratory pressure at 7 months
timeFrame: 7 months
measure: Maximal expiratory pressure at 7 months
timeFrame: 7 months
measure: Maximal inspiratory pressure at 1 month
timeFrame: 1 month
measure: Maximal expiratory pressure at 1 month
timeFrame: 1 month
measure: Skeletal muscle mass at 7 months
timeFrame: 7 months
measure: Skeletal muscle mass at 1 month
timeFrame: 1 month
measure: Appendicular muscle mass at 1 month
timeFrame: 1 month
measure: Appendicular muscle mass at 7 months
timeFrame: 7 months
measure: Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 7 months
timeFrame: 7 months
measure: Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 7 months
timeFrame: 7 months
measure: Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 1 month
timeFrame: 1 month
measure: Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 1 month
timeFrame: 1 month
measure: Change of 6 minutes walking test at 1 month
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
state: Songpa
Study officials:
affiliation: Asan Medical Center
name: Jang Ho Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: