Pulmonary Rehabilitation Before Lung Cancer Resection

Status:	Active, not recruiting
Conditions:	Lung Cancer, Lung Cancer, Cancer, Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:	Oncology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	12/7/2018
Start Date:	March 15, 2017
End Date:	December 2020

This is a study funded by the National Institute of Health. The rationale for the need of
this research is the lack of any well proven risk-reducing intervention that may decrease the
morbidity of lung cancer resection in patients with COPD or that may improve their quality of
life trajectory, a meaningful outcome in the overall disease progression. The proposed
intervention is unique as it combines exercise and behavioral interventions that were pilot
tested in a randomized single-blinded controlled design in the proposed population and proved
feasible and potentially effective. The aim is to test the effect of the proposed
rehabilitation on length of stay, pulmonary complications and quality of life trajectory.

Prospectively, 194 patients will be randomized to either ten sessions of preoperative
pulmonary rehabilitation (PR) vs. standard care at a number of healthcare centers throughout
the United States. This study will be open for 36 months. Randomization will be stratified by
three variables: very severe lung function (yes vs. no), prior neo-adjuvant chemotherapy for
this operation (yes vs. no) and open thoracotomy vs. video assisted thoracoscopy. The primary
and secondary objectives are provided below.

Primary Objective:

To prospectively determine the effect of 10 sessions of customized preoperative PR on the
length of hospital stay in patients that undergo a lung cancer resection and have COPD
compared to a matched control group. Hypothesis: Ten sessions of customized preoperative PR
will significantly reduce the length of hospital stay.

Secondary Objectives:

1. To prospectively determine the effect of 10 sessions of customized preoperative PR on
the number of postoperative complications in patients that undergo a lung cancer
resection and have COPD compared to a matched control group.

- Hypothesis: Ten sessions of customized preoperative PR will significantly reduce
the number of postoperative pulmonary complications.

2. To prospectively determine the effect of a 10-session preoperative PR on the trajectory
of quality of life at 3 and 6 months after the curative resection compared to a matched
control group.

- Hypothesis: Ten sessions of customized preoperative PR will significantly and
meaningfully (more than the minimal clinically important difference) improve
quality of life after surgery compared to a control group.

Patients will be followed at 3 and 6 months post-surgery.

1. Patient is scheduled to undergo NSCLC resection: video assisted thoracoscopy (VATS) or
open thoracotomy for: limited resection, lobectomy, or pneumonectomy. Surgery must not
be scheduled to take place < 3 weeks after registration.

2. Patient has a doctor diagnosis of COPD.

3. Patient is a current or ex-smoker with a smoking history of ≥ 10 pack years.
(Calculated by multiplying the number of packs of cigarettes smoked per day by the
number of years the person has smoked. For example, 1 pack-year is equal to smoking 20
cigarettes (1 pack) per day for 1 year, or 40 cigarettes per day for half a year, and
so on).

4. Age ≥ 18 yrs

We found this trial at

sites

Mayo Clinic Florida

4500 San Pablo Rd S
Jacksonville, Florida 32224

(904) 953-2000