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

The Ohio State University

Status: Withdrawn

Conditions: Stage IIIB Non-small Cell Lung Cancer; Radiation Toxicity; Stage IV Non-small Cell Lung Cancer; Cachexia; Fatigue; Stage IIIA Non-small Cell Lung Cancer; Pulmonary Complications; Recurrent Non-small Cell Lung Cancer

Treatments: Procedure: quality-of-life assessment; Other: questionnaire administration; Procedure: pulmonary complications management/prevention; Behavioral: exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02017925

NCI-2013-02215 (Registry Identifier)

OSU-13044

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm I (early intervention)

Experimental group

Description:

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).

Treatment:

Behavioral: exercise intervention

Other: questionnaire administration

Procedure: pulmonary complications management/prevention

Procedure: quality-of-life assessment

Arm II (late intervention)

Experimental group

Description:

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

Treatment:

Behavioral: exercise intervention

Other: questionnaire administration

Procedure: pulmonary complications management/prevention

Procedure: quality-of-life assessment