Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation

Pulmonary Rehabilitation in Locally Advanced Non-Small Cell Lung Cancer

This randomized clinical trial studies pulmonary rehabilitation in improving lung function in patients with locally advanced non-small cell lung cancer undergoing chemoradiation. Individualized exercise rehabilitation programs may reduce breathing problems and improve quality of life in patients with non-small cell lung cancer. It is not yet known whether pulmonary rehabilitation is more effective when started during or after cancer treatment.

Study Overview

• Status: Withdrawn
• Conditions: Fatigue; Cachexia; Radiation Toxicity; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Pulmonary Complications; Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
• Intervention / Treatment: Other: questionnaire administration; Procedure: quality-of-life assessment; Behavioral: exercise intervention; Procedure: pulmonary complications management/prevention

Detailed Description

PRIMARY OBJECTIVES:

I. To determine feasibility of pulmonary rehabilitation (PR) in patients with locally advanced unresectable non-small cell lung cancer (NSCLC) undergoing definite chemotherapy and radiation therapy.

II. To measure exercise capacity and respiratory symptoms in lung cancer patients receiving chemotherapy and radiation before and after pulmonary rehabilitation.

III. To compare if there are any differences in symptom relief, exercise capacity, and cancer treatment tolerability between performing pulmonary rehabilitation during chemo-radiation versus after completion of lung cancer treatment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Beginning within 2 weeks of starting chemoradiation, patients undergo an individualized rehabilitation program comprising aerobic exercise and strength training, including treadmill walking, stationary bicycle, NU-Step, upper body resistance training and breathing retraining, 3 times per week for 8 weeks (36 sessions).

ARM II: Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who have been diagnosed with locally advanced unresectable NSCLC undergoing definite chemo-radiation with curative intent
• Patients must be able to sign informed consent
• Patients who qualify for pulmonary rehabilitation as part of the standard of care and are covered by medical insurance
• Patients must be able to ambulate a minimum of 100 feet prior to enrollment in pulmonary rehab
• Patients must be willing and able to travel to the pulmonary rehabilitation site at the Morehouse Medical Plaza

Exclusion Criteria:

• Tumor resection candidates
• If survival is deemed less than 6 months for any medical condition
• If they have angina or unstable coronary disease
• Congestive heart failure refractory to medical management
• Malignancy with bone instability
• Inmates

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (early intervention); Beginning within 2 weeks of starting chemoradiation, patients undergo an individualized rehabilitation program comprising aerobic exercise and strength training, including treadmill walking, stationary bicycle, NU-Step, upper body resistance training and breathing retraining, 3 times per week for 8 weeks (36 sessions).	Other: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Behavioral: exercise intervention; Undergo pulmonary rehabilitation; Procedure: pulmonary complications management/prevention; Undergo pulmonary rehabilitation
Experimental: Arm II (late intervention); Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.	Other: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Behavioral: exercise intervention; Undergo pulmonary rehabilitation; Procedure: pulmonary complications management/prevention; Undergo pulmonary rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent improvement in the 6 minute walk from prior to post PR	Either a two-sided t-test or a Wilcoxon-rank sum test will be used to test the difference in the improvement of the 6 minute walk depending on the distribution. This test will be used to compare the difference in improvement between PR during chemo-radiation of NSCLC patients and PR 8 weeks post chemo-radiation. Linear regression will be used to estimate which clinical characteristics and patient demographics are associated with improvement in 6 minute walk. The study population will be described using means and standard deviations or medians and the interquartile range.	Baseline to up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score		Baseline to up to 8 weeks
Feasibility of the program, based on number of patients attending the sessions throughout the 8 weeks	Either Pearson's chi-square of Fisher's exact methods will be used to test if the feasibility differs across groups. Logistic regression will be used to estimate which clinical characteristics and patient demographics are associated with feasibility.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Patrick Nana-Sinkam, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: NSCLC; Non-Small Cell Lung Cancer; Pulmonary Rehabilitation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Body Weight; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Body Weight Changes; Emaciation; Weight Loss; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Cachexia
• Other Study ID Numbers: OSU-13044; NCI-2013-02215 (Registry Identifier: CTRP (Clinical Trial Reporting Program))