Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02017925 |
Recruitment Status :
Withdrawn
First Posted : December 23, 2013
Last Update Posted : April 13, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cachexia Fatigue Pulmonary Complications Radiation Toxicity Recurrent Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer | Behavioral: exercise intervention Procedure: pulmonary complications management/prevention Procedure: quality-of-life assessment Other: questionnaire administration | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Pulmonary Rehabilitation in Locally Advanced Non-Small Cell Lung Cancer |
Study Start Date : | October 2013 |
Estimated Primary Completion Date : | March 2017 |
Estimated Study Completion Date : | March 2017 |

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).
|
Behavioral: exercise intervention
Undergo pulmonary rehabilitation Procedure: pulmonary complications management/prevention Undergo pulmonary rehabilitation Procedure: quality-of-life assessment Ancillary studies
Other Name: quality of life assessment Other: questionnaire administration Ancillary studies |
Experimental: Arm II (late intervention)
Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.
|
Behavioral: exercise intervention
Undergo pulmonary rehabilitation Procedure: pulmonary complications management/prevention Undergo pulmonary rehabilitation Procedure: quality-of-life assessment Ancillary studies
Other Name: quality of life assessment Other: questionnaire administration Ancillary studies |
- Percent improvement in the 6 minute walk from prior to post PR [ Time Frame: 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.
- Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score [ Time Frame: Baseline to up to 8 weeks ]
- Feasibility of the program, based on number of patients attending the sessions throughout the 8 weeks [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017925
Principal Investigator: | Patrick Nana-Sinkam, MD | Ohio State University Comprehensive Cancer Center |
Responsible Party: | Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT02017925 |
Other Study ID Numbers: |
OSU-13044 NCI-2013-02215 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | December 23, 2013 Key Record Dates |
Last Update Posted: | April 13, 2017 |
Last Verified: | April 2017 |
Pulmonary Rehabilitation Non-Small Cell Lung Cancer NSCLC |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Cachexia Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Emaciation Weight Loss Body Weight Changes Body Weight |