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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Michael Ezzie, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02017925
First received: December 17, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pulmonary Rehabilitation in Locally Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Percent improvement in the 6 minute walk from prior to post PR [ Time Frame: Baseline to up to 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score [ Time Frame: Baseline to up to 8 weeks ] [ Designated as safety issue: No ]
  • Feasibility of the program, based on number of patients attending the sessions throughout the 8 weeks [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: October 2013
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017925

Contacts
Contact: Micahel Ezzie, MD 614-293-4925 michael.ezzie@osumc.edu

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Michael Ezzie, MD    614-293-4925    Michael.ezzie@osumc.edu   
Principal Investigator: Michael Ezzie, MD         
Sub-Investigator: Hiram Rivas-Perez, MD         
Sub-Investigator: Philip Diaz, MD         
Sub-Investigator: Miguel Villalona, MD         
Sub-Investigator: Vincent Esguerra, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Michael Ezzie Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Ezzie, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02017925     History of Changes
Other Study ID Numbers: OSU-13044, NCI-2013-02215
Study First Received: December 17, 2013
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Pulmonary Rehabilitation
Non-Small Cell Lung Cancer
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Cachexia
Fatigue
Lung Neoplasms
Radiation Injuries
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on July 28, 2014