Clinical trial NCT02017925: Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation
Official title: Pulmonary Rehabilitation in Locally Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Keywords: Pulmonary Rehabilitation
Non-Small Cell Lung Cancer
NSCLC
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percent improvement in the 6 minute walk from prior to post PR
timeFrame: Baseline to up to 8 weeks
Secondary outcomes:
measure: Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score
timeFrame: Baseline to up to 8 weeks
measure: Feasibility of the program, based on number of patients attending the sessions throughout the 8 weeks
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Patrick Nana-Sinkam, MD
role: PRINCIPAL_INVESTIGATOR
References: