Pulmonary Resection And Intensive Rehabilitation (PUREAIR)

July 12, 2019 updated by: SARATENCONI, Arcispedale Santa Maria Nuova-IRCCS

Effects of Early Pulmonary Rehabilitation and Long-term Exercise on Functioning, Quality of Life and Postoperative Outcome in Lung Cancer Patients

Lung cancer is the leading cause of cancer death in males, and is increasing in females. Up to 73% of affected patients present with Chronic Obstructive Pulmonary Disease (COPD). Most lung cancer patients have an average survival of about 8 months from diagnosis. Lobectomy for initial stages has demonstrated higher survival rates, but only 15% to 25% are surgical candidates; unfortunately, cardiopulmonary impairment mainly due to coexisting COPD reduces this number and patients undergo medical treatment or marginal lung resection, with minor functional impact but possible ineffective control of disease.

Furthermore, COPD is associated with increased postoperative morbidity and mortality, longer in-hospital stay, need for additional treatments, and a rise in sanitary costs.

The investigators planned a randomised trial on surgical candidates to assess the effect of comprehensive pulmonary rehabilitation on functional and surgical outcomes, functioning, and Quality of Life (QoL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preoperative pulmonary rehabilitation ameliorates functional parameters responsible for inoperability in COPD patients; candidates for surgery could benefit from this functional improvement in terms of wider possible lung resection and lower incidence of postoperative complication.

Likewise, postoperative respiratory rehabilitation significantly improves respiratory function and exercise capacity in treated patients but the effect on long-term functioning and QoL is not known.

Current studies present small-sized samples and short follow up. The impact of comprehensive rehabilitation on overall functioning, depression, pain, and QoL has only been reported for COPD patients. Moreover, the rate of anatomical resection and postoperative morbidity in compromised COPD patients treated with intensive rehabilitation has never before been reported in randomised trials.

The investigators hypothesise that: comprehensive rehabilitation intervention in lung cancer patients eligible for surgical treatment may reduce pain, comorbidity (pneumonia and other pulmonary complications requiring further treatments), depression, and deconditioning and improve QoL 1 to 6 month after surgery; active lifestyle and regular follow up may reduce long-term quality of life decline; early pulmonary rehabilitation can improve lung function tests making proper surgical treatment with curative intent possible in patients affected by COPD otherwise treated medically or by marginal operations.

Investigators have planned a randomised trial with 2 parallel arms: all patients with resectable (T1-2 N0-1) diagnosed or suspected lung cancer will be enrolled in the study at pre-operative interview with thoracic surgery consultant and then randomised by the physician data manager (T0). The Intervention Group (IG) will receive an overall rehabilitation treatment based on 10 sessions of pre-operative outpatient PR, early inpatient post-operative PR, and long-term exercise beginning 1 month after surgery and lasting for 15 sessions. Control Group (CG) will receive Standard Care (SC) based upon physiatrist counselling the day before surgery and early inpatient post-operative PR. Both groups will receive re-evaluation and, if necessary, optimization of COPD therapy before entering the study; final follow up will be at 6 months after surgery in both groups (T3), intermediate evaluations are planned immediately before surgery (T1) and 1 month after surgical treatment (T2).

The 6 minutes walk test (6MWT) proved to correlate with functional status of patients with respiratory impairments; measurement of the impact of Pulmonary Rehabilitation (PR) on 6MWT is the primary outcome of our study. Investigators expect that this kind of treatment will improve exercise tolerance expressed by the 6MWT, assessed at T0, T1, T2 and T3 in IG. Values of 6MWT in CG will be assessed at T0 and T3 (T1 only if changes in therapy have occurred).

It has been demonstrated that PR and educational therapy optimize respiratory function in COPD patients. Investigators will asses the changes in pulmonary function with Lung Function Tests (LFT): complete spirometry (static and dynamic volumes and Diffusing Capacity of Carbon Oxide) will be performed at T0, T1 e T3 in IC. The CG will be evaluated at T0 and T3 (T1 only if changes in therapy have occurred).

COPD patients eligible for lung cancer surgery often undergo sub-lobar resection to preserve respiratory function; PR could reduce lung impairment and increase the rate of lobectomies in this subset of patients. By optimizing lung function, investigators expect a reduction in post-operative complications and length of hospital stay. This will be evaluated 1 month after surgery (T2).

The therapeutic strategy of lung cancer is very complex; this causes both physical and psychological symptoms and significantly impairs patients' QoL. This important outcome will be assessed with Short-Form 12 questionnaire (SF12) at T0 and T3. Pain and depression will also be monitored with specific scales: the Numeric Rating Scale (NRS) for pain and the Hospital Anxiety and Depression Scale (HADS) to measure depression. Pain evaluations will be planned at T0, T2 and T3, depression at T0, T1 and T3.

Since there are no published data for mean and standard deviations of 6MWT after lung surgery with or without treatment, Cohen's medium effect size (d=0.5) has been used to compute sample size (n=140).

Normality for continuous variables will be assessed by Shapiro-Wilk test to decide the statistical technique to use. Thus, Student t will be used for normal variables, while Wilcoxon-Mann-Whitney test will be used for the others.

Categorical variables (presence/absence of any complication) will be analyzed through 2x2 tables and significance assessed with Chi-squared test. Risks will be described by Odds Ratio and related Confidence Interval.

With regard to primary endpoint, IC is expected to improve 6MWT at 6 months by at least 25 metres compared to CG. We also expect an improvement in postoperative outcome (less morbidity and shorter in-hospital stay) and long-term QoL, and in pain and depression levels.

An overall 10% drop-out rate is estimated, due to factors like perioperative death or major complications and need for adjuvant treatments (which would overlap postoperative rehabilitation and deeply impact on results).

Moreover, overall randomization could produce an imbalance between the two groups in some features; in presence of significant non-homogeneity of treated versus control arm, propensity score matching analysis will be applied to reduce bias due to confounding factors.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Reggio Emilia, Italy, 42123
        • Arcispedale_SMN
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Arcispedale_SMN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stage 1 to 2B diagnosed or suspected NSCLC in operable patients

Exclusion Criteria:

  • unresectable disease, N2 disease requiring induction or postoperative chemotherapy
  • patients unfit for physical exercise requested by rehabilitation and assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Standard Care
Procedure: Standard care
Control Group (CG) will receive Standard Care (SC) based upon physiatrist counselling the day before surgery and early inpatient post-operative PR.
Experimental: Interventional Group
Pulmonary rehabilitation
Procedure: Pulmonary Rehabilitation
The Intervention Group (IG) will receive an overall rehabilitation treatment based on 10 sessions of pre-operative outpatient PR, early inpatient post-operative PR, and long-term exercise beginning 1 month after surgery and lasting for 15 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6 Minutes Walking Test
Time Frame: Baseline, Preoperative, 1 month, 6 month
6MWT
Baseline, Preoperative, 1 month, 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pulmonary Function Tests
Time Frame: Baseline, Preoperative, 1 month, 6 months
PFT
Baseline, Preoperative, 1 month, 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the rate of lobar resection in borderline patients
Time Frame: Baseline, Postoperative
Number of lobar resection recorded
Baseline, Postoperative
Change of the rate of postoperative complications
Time Frame: Baseline, Postoperaive, 1 month
Number of postoperative complications recorded
Baseline, Postoperaive, 1 month
Change in Quality of life
Time Frame: Baseline, 6 months
SF12 questionnaire
Baseline, 6 months
Change in pain perception
Time Frame: Baseline, 1 month, 6 months
NRS questionnaire
Baseline, 1 month, 6 months
Change in the level of depression
Time Frame: Baseline, postoperative, 6 months
HADS questionnaire
Baseline, postoperative, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcispedale Santa Maria Nuova-IRCCS

Collaborators

Ministry of Health, Italy

Investigators

  • Principal Investigator: Sara Tenconi, Dr, Arcispedale Santa Maria Nuova-IRCCS
  • Study Director: Stefania Fugazzaro, Dr, Arcispedale Santa Maria Nuova-IRCCS
  • Study Chair: Cristian Rapicetta, Dr, Arcispedale Santa Maria Nuova-IRCCS
  • Study Chair: Roberto Piro, Dr, Arcispedale Santa Maria Nuova-IRCCS
  • Study Chair: Besa Kopliku, Dr, Arcispedale Santa Maria Nuova-IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-2011-02351711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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