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

Not Applicable

Withdrawn

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

• Registration Number: NCT02017925
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (early intervention)	questionnaire administration	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 (late intervention)	questionnaire administration	Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.
Arm I (early intervention)	exercise 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).
Arm I (early intervention)	quality-of-life assessment	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 I (early intervention)	pulmonary complications management/prevention	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 (late intervention)	pulmonary complications management/prevention	Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.
Arm II (late intervention)	quality-of-life assessment	Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.
Arm II (late intervention)	exercise intervention	Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.

Primary Outcome Measures

Name	Time	Method
Percent improvement in the 6 minute walk from prior to post PR	Baseline to up to 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility of the program, based on number of patients attending the sessions throughout the 8 weeks	Up to 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.
Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score	Baseline to up to 8 weeks