Beneficial Effect of Pulmonary Rehabilitation in Lung Cancer Patients Receiving Radiation Therapy

Not Applicable

• Conditions: Lung Neoplasm Malignant
• Interventions: Behavioral: Pulmonary rehabilitation

• Registration Number: NCT05414188
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2022-05-30
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-08
• Study First Posted: 2022-06-10
• Last Update Posted: 2022-06-10
• Study Start: 2022-06-14
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary rehabilitation group	Pulmonary rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Change of 6 minutes walking test at 7 months	7 months	Change of walking distance from baseline 6 minutes walking test at 7 months

Secondary Outcome Measures

Name	Time	Method
Forced Vital Capacity at 7 months	7 months	Forced Vital Capacity (L, predicted percentage) at 7 months
Forced Expiratory Volume in 1 sec at 1 month	1 month	Forced Expiratory Volume in 1 sec (L, predicted percentage) at 1 month
Carbon monoxide diffusing capacity at 1 month	1 month	Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 1 month
Forced Expiratory Volume in 1 sec at 7 months	7 months	Forced Expiratory Volume in 1 sec (L, predicted percentage) at 7 months
Forced Vital Capacity at 1 month	1 month	Forced Vital Capacity (L, predicted percentage) at 1 month
Carbon monoxide diffusing capacity at 7 months	7 months	Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 7 months
Change of dyspnea scale at 1 month	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
Maximal inspiratory pressure at 7 months	7 months	To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry
Maximal expiratory pressure at 1 month	1 month	To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry
Radiation therapy related pneumonitis	From the initiation of radiation therapy to 7 months at end of radiation therapy	Radiation therapy related pneumonitis requiring steroid therapy
Skeletal muscle mass at 1 month	1 month	Investigators will measure the skeletal muscle mass by bioimpedance
Appendicular muscle mass at 1 month	1 month	Investigators will measure the appendicular muscle mass by bioimpedance
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 7 months	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)
All cause mortality	From the initiation of radiation therapy to 7 months at end of radiation therapy	All cause mortality during study periods
Maximal expiratory pressure at 7 months	7 months	To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry
Appendicular muscle mass at 7 months	7 months	Investigators will measure the appendicular muscle mass by bioimpedance
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 7 months	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)
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 1 month	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)
Change of dyspnea scale at 7 months	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
Skeletal muscle mass at 7 months	7 months	Investigators will measure the skeletal muscle mass by bioimpedance
Change of 6 minutes walking test at 1 month	1 month	Change of walking distance from baseline 6 minutes walking test at 1 month
Grip strength at 7 months	7 months	Grip strength will be measured by digital group hand dynamometer
Grip strength at 1 month	1 month	Grip strength will be measured by digital group hand dynamometer
Maximal inspiratory pressure at 1 month	1 month	To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry
Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 1 month	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)

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, Songpa, Korea, Republic of