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

Lung Neoplasm Malignant Clinical Trial

Official title:

The Improvement of the Quality of Life and Exercise Capacity Through Pulmonary Rehabilitation in Lung Cancer Patients Receiving Radiation Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05414188
• Other study ID #: 2022-0483
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Asan Medical Center
• Contact: Sei Won Lee, MD, PhD
• Phone: +82-2-3010-3990
• Email: iseiwon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasm Malignant
• Lung Neoplasms
• Neoplasms

Intervention

Behavioral:
• Pulmonary rehabilitation
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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul	Songpa

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of 6 minutes walking test at 7 months	Change of walking distance from baseline 6 minutes walking test at 7 months	7 months
Secondary	All cause mortality	All cause mortality during study periods	From the initiation of radiation therapy to 7 months at end of radiation therapy
Secondary	Radiation therapy related pneumonitis	Radiation therapy related pneumonitis requiring steroid therapy	From the initiation of radiation therapy to 7 months at end of radiation therapy
Secondary	Forced Expiratory Volume in 1 sec at 7 months	Forced Expiratory Volume in 1 sec (L, predicted percentage) at 7 months	7 months
Secondary	Forced Expiratory Volume in 1 sec at 1 month	Forced Expiratory Volume in 1 sec (L, predicted percentage) at 1 month	1 month
Secondary	Forced Vital Capacity at 7 months	Forced Vital Capacity (L, predicted percentage) at 7 months	7 months
Secondary	Forced Vital Capacity at 1 month	Forced Vital Capacity (L, predicted percentage) at 1 month	1 month
Secondary	Carbon monoxide diffusing capacity at 7 months	Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 7 months	7 months
Secondary	Carbon monoxide diffusing capacity at 1 month	Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 1 month	1 month
Secondary	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	7 months
Secondary	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	1 month
Secondary	Grip strength at 7 months	Grip strength will be measured by digital group hand dynamometer	7 months
Secondary	Grip strength at 1 month	Grip strength will be measured by digital group hand dynamometer	1 month
Secondary	Maximal inspiratory pressure at 7 months	To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry	7 months
Secondary	Maximal expiratory pressure at 7 months	To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry	7 months
Secondary	Maximal inspiratory pressure at 1 month	To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry	1 month
Secondary	Maximal expiratory pressure at 1 month	To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry	1 month
Secondary	Skeletal muscle mass at 7 months	Investigators will measure the skeletal muscle mass by bioimpedance	7 months
Secondary	Skeletal muscle mass at 1 month	Investigators will measure the skeletal muscle mass by bioimpedance	1 month
Secondary	Appendicular muscle mass at 1 month	Investigators will measure the appendicular muscle mass by bioimpedance	1 month
Secondary	Appendicular muscle mass at 7 months	Investigators will measure the appendicular muscle mass by bioimpedance	7 months
Secondary	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)	7 months
Secondary	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)	7 months
Secondary	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)	1 month
Secondary	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)	1 month
Secondary	Change of 6 minutes walking test at 1 month	Change of walking distance from baseline 6 minutes walking test at 1 month	1 month