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

NCT ID: NCT02017925

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

exercise intervention

Intervention Type: BEHAVIORAL

Undergo pulmonary rehabilitation

pulmonary complications management/prevention

Intervention Type: PROCEDURE

Undergo pulmonary rehabilitation

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Arm II (late intervention)

Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.

Group Type: EXPERIMENTAL

exercise intervention

Intervention Type: BEHAVIORAL

Undergo pulmonary rehabilitation

pulmonary complications management/prevention

Intervention Type: PROCEDURE

Undergo pulmonary rehabilitation

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Interventions

exercise intervention

Undergo pulmonary rehabilitation

Intervention Type: BEHAVIORAL

pulmonary complications management/prevention

Undergo pulmonary rehabilitation

Intervention Type: PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

quality of life assessment

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Nana-Sinkam, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2013-02215

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-13044

Identifier Type: -

Identifier Source: org_study_id