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

NCT05414188 | Unknown

• 1 other identifier: 2022-0483
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasm Malignant

Keywords

Pulmonary rehabilitation; Radiation therapy; Lung cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• All cause mortality

  From the initiation of radiation therapy to 7 months at end of radiation therapy

• Radiation therapy related pneumonitis

  From the initiation of radiation therapy to 7 months at end of radiation therapy

• Forced Expiratory Volume in 1 sec at 7 months

  7 months

• Forced Expiratory Volume in 1 sec at 1 month

  1 month

• Forced Vital Capacity at 7 months

  7 months

Study Arms (2)

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.

Behavioral: Pulmonary rehabilitation

Control group

NO INTERVENTION

Patients will receive the radiation therapy according to the existing schedule. There will be no additional treatment

Interventions

Pulmonary rehabilitation BEHAVIORAL

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.

Pulmonary rehabilitation group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, Songpa, 05505, South Korea

Location

Related Publications (1)

• 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.

  PMID: 40306134 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jang Ho Lee, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sei Won Lee, MD, PhD

CONTACT

+82-2-3010-3990; iseiwon@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 10, 2022
• Study Start: June 14, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

KR (1)