Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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Recruitment Status : Withdrawn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
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score [ Time Frame: Baseline to up to 8 weeks ]
  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Patrick Nana-Sinkam, MD Ohio State University Comprehensive Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
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
Keywords provided by Ohio State University Comprehensive Cancer Center:
Pulmonary Rehabilitation
Non-Small Cell Lung Cancer
NSCLC
Additional relevant MeSH terms:
Layout table for MeSH terms
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