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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Neoplasm Malignant
• Intervention / Treatment: Behavioral: Pulmonary rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sei Won Lee, MD, PhD; Phone Number: 3990 +82-2-3010-3990; Email: iseiwon@gmail.com

Study Locations

• Korea, Republic of
  • Songpa
    • Seoul, Songpa, Korea, Republic of, 05505
      • Asan Medical Center, University of Ulsan College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pulmonary rehabilitation group; 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.	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.
No Intervention: Control group; Patients will receive the radiation therapy according to the existing schedule. There will be no additional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	All cause mortality during study periods	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	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	7 months
Forced Expiratory Volume in 1 sec at 1 month	Forced Expiratory Volume in 1 sec (L, predicted percentage) at 1 month	1 month
Forced Vital Capacity at 7 months	Forced Vital Capacity (L, predicted percentage) at 7 months	7 months
Forced Vital Capacity at 1 month	Forced Vital Capacity (L, predicted percentage) at 1 month	1 month
Carbon monoxide diffusing capacity at 7 months	Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 7 months	7 months
Carbon monoxide diffusing capacity at 1 month	Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 1 month	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	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	1 month
Grip strength at 7 months	Grip strength will be measured by digital group hand dynamometer	7 months
Grip strength at 1 month	Grip strength will be measured by digital group hand dynamometer	1 month
Maximal inspiratory pressure at 7 months	To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry	7 months
Maximal expiratory pressure at 7 months	To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry	7 months
Maximal inspiratory pressure at 1 month	To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry	1 month
Maximal expiratory pressure at 1 month	To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry	1 month
Skeletal muscle mass at 7 months	Investigators will measure the skeletal muscle mass by bioimpedance	7 months
Skeletal muscle mass at 1 month	Investigators will measure the skeletal muscle mass by bioimpedance	1 month
Appendicular muscle mass at 1 month	Investigators will measure the appendicular muscle mass by bioimpedance	1 month
Appendicular muscle mass at 7 months	Investigators will measure the appendicular muscle mass by bioimpedance	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)	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)	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)	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)	1 month
Change of 6 minutes walking test at 1 month	Change of walking distance from baseline 6 minutes walking test at 1 month	1 month

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Jang Ho Lee, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): June 14, 2022
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Lung cancer; Pulmonary rehabilitation; Radiation therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2022-0483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Investigators anticipate our study will be finished until December 31, 2023. After end of the study, investigators might consider to share the individual participant data.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No