Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation
Conditions
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
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Pulmonary Rehabilitation, Non-Small Cell Lung Cancer, NSCLC
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: exercise intervention Type: Behavioral
Name: pulmonary complications management/prevention Type: Procedure
Name: quality-of-life assessment Type: Procedure
Name: questionnaire administration Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Status: Recruiting
Contact: Patrick Nana-Sinkam, MD - 614-293-6939 - Patrick.Nana-Sinkam@osumc.edu
Start Date
October 2013
Sponsors
Ohio State University Comprehensive Cancer Center
Source
Ohio State University Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page