NCT02405273

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 11, 2025

Status Verified

July 1, 2019

Enrollment Period

4.2 years

First QC Date

March 18, 2015

Last Update Submit

June 6, 2025

Conditions

Lung Cancer

Keywords

Lung CancerSurgeryCOPDRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in 6 Minutes Walking Test

    6MWT

    Baseline, Preoperative, 1 month, 6 month

Secondary Outcomes (1)

  • Change in Pulmonary Function Tests

    Baseline, Preoperative, 1 month, 6 months

Other Outcomes (5)

  • Change of the rate of lobar resection in borderline patients

    Baseline, Postoperative

  • Change of the rate of postoperative complications

    Baseline, Postoperaive, 1 month

  • Change in Quality of life

    Baseline, 6 months

  • +2 more other outcomes

Study Arms (2)

Interventional Group

EXPERIMENTAL

Pulmonary rehabilitation

Procedure: Pulmonary Rehabilitation

Control Group

ACTIVE COMPARATOR

Standard Care

Procedure: Standard care

Interventions

Pulmonary RehabilitationPROCEDURE

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

Interventional Group
Standard carePROCEDURE

Control Group (CG) will receive Standard Care (SC) based upon physiatrist counselling the day before surgery and early inpatient post-operative PR.

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arcispedale_SMN

Reggio Emilia, Italy, 42123, Italy

Location

Arcispedale_SMN

Reggio Emilia, RE, 42123, Italy

Location

Related Publications (18)

  • Rueda JR, Sola I, Pascual A, Subirana Casacuberta M. Non-invasive interventions for improving well-being and quality of life in patients with lung cancer. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004282. doi: 10.1002/14651858.CD004282.pub3.

    PMID: 21901689BACKGROUND

  • Loganathan RS, Stover DE, Shi W, Venkatraman E. Prevalence of COPD in women compared to men around the time of diagnosis of primary lung cancer. Chest. 2006 May;129(5):1305-12. doi: 10.1378/chest.129.5.1305.

    PMID: 16685023BACKGROUND

  • Shannon VR. Role of pulmonary rehabilitation in the management of patients with lung cancer. Curr Opin Pulm Med. 2010 Jul;16(4):334-9. doi: 10.1097/MCP.0b013e32833a897d.

    PMID: 20531082BACKGROUND

  • Divisi D, Di Francesco C, Di Leonardo G, Crisci R. Preoperative pulmonary rehabilitation in patients with lung cancer and chronic obstructive pulmonary disease. Eur J Cardiothorac Surg. 2013 Feb;43(2):293-6. doi: 10.1093/ejcts/ezs257. Epub 2012 May 15.

    PMID: 22588033BACKGROUND

  • Schroedl C, Kalhan R. Incidence, treatment options, and outcomes of lung cancer in patients with chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2012 Mar;18(2):131-7. doi: 10.1097/MCP.0b013e32834f2080.

    PMID: 22262137BACKGROUND

  • Alberg AJ, Ford JG, Samet JM; American College of Chest Physicians. Epidemiology of lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):29S-55S. doi: 10.1378/chest.07-1347.

    PMID: 17873159BACKGROUND

  • Nici L, Raskin J, Rochester CL, Bourbeau JC, Carlin BW, Casaburi R, Celli BR, Cote C, Crouch RH, Diez-Morales LF, Donner CF, Fahy BF, Garvey C, Goldstein R, Lane-Reticker A, Lareau SC, Make B, Maltais F, McCormick J, Morgan MD, Ries A, Troosters T, ZuWallack R. Pulmonary rehabilitation: WHAT WE KNOW AND WHAT WE NEED TO KNOW. J Cardiopulm Rehabil Prev. 2009 May-Jun;29(3):141-51. doi: 10.1097/HCR.0b013e3181a85cda.

    PMID: 19471135BACKGROUND

  • Cesario A, Ferri L, Galetta D, Pasqua F, Bonassi S, Clini E, Biscione G, Cardaci V, di Toro S, Zarzana A, Margaritora S, Piraino A, Russo P, Sterzi S, Granone P. Post-operative respiratory rehabilitation after lung resection for non-small cell lung cancer. Lung Cancer. 2007 Aug;57(2):175-80. doi: 10.1016/j.lungcan.2007.02.017. Epub 2007 Apr 17.

    PMID: 17442449BACKGROUND

  • Granger CL, Chao C, McDonald CF, Berney S, Denehy L. Safety and feasibility of an exercise intervention for patients following lung resection: a pilot randomized controlled trial. Integr Cancer Ther. 2013 May;12(3):213-24. doi: 10.1177/1534735412450461. Epub 2012 Jul 16.

    PMID: 22801943BACKGROUND

  • Jones LE, Doebbeling CC. Beyond the traditional prognostic indicators: the impact of primary care utilization on cancer survival. J Clin Oncol. 2007 Dec 20;25(36):5793-9. doi: 10.1200/JCO.2007.13.6127.

    PMID: 18089877BACKGROUND

  • Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12.

    PMID: 21663994BACKGROUND

  • Morano MT, Araujo AS, Nascimento FB, da Silva GF, Mesquita R, Pinto JS, de Moraes Filho MO, Pereira ED. Preoperative pulmonary rehabilitation versus chest physical therapy in patients undergoing lung cancer resection: a pilot randomized controlled trial. Arch Phys Med Rehabil. 2013 Jan;94(1):53-8. doi: 10.1016/j.apmr.2012.08.206. Epub 2012 Aug 24.

    PMID: 22926460BACKGROUND

  • Spruit MA, Janssen PP, Willemsen SC, Hochstenbag MM, Wouters EF. Exercise capacity before and after an 8-week multidisciplinary inpatient rehabilitation program in lung cancer patients: a pilot study. Lung Cancer. 2006 May;52(2):257-60. doi: 10.1016/j.lungcan.2006.01.003. Epub 2006 Mar 9.

    PMID: 16529844BACKGROUND

  • Arbane G, Tropman D, Jackson D, Garrod R. Evaluation of an early exercise intervention after thoracotomy for non-small cell lung cancer (NSCLC), effects on quality of life, muscle strength and exercise tolerance: randomised controlled trial. Lung Cancer. 2011 Feb;71(2):229-34. doi: 10.1016/j.lungcan.2010.04.025. Epub 2010 Jun 11.

    PMID: 20541832BACKGROUND

  • Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

    PMID: 20818875BACKGROUND

  • Holland AE, Hill CJ, Rasekaba T, Lee A, Naughton MT, McDonald CF. Updating the minimal important difference for six-minute walk distance in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2010 Feb;91(2):221-5. doi: 10.1016/j.apmr.2009.10.017.

    PMID: 20159125BACKGROUND

  • Perrotta F, Cennamo A, Cerqua FS, Stefanelli F, Bianco A, Musella S, Rispoli M, Salvi R, Meoli I. Effects of a high-intensity pulmonary rehabilitation program on the minute ventilation/carbon dioxide output slope during exercise in a cohort of patients with COPD undergoing lung resection for non-small cell lung cancer. J Bras Pneumol. 2019 Oct 14;45(6):e20180132. doi: 10.1590/1806-3713/e20180132. eCollection 2019.

    PMID: 31618297DERIVED

  • Fugazzaro S, Costi S, Mainini C, Kopliku B, Rapicetta C, Piro R, Bardelli R, Rebelo PFS, Galeone C, Sgarbi G, Lococo F, Paci M, Ricchetti T, Cavuto S, Merlo DF, Tenconi S. PUREAIR protocol: randomized controlled trial of intensive pulmonary rehabilitation versus standard care in patients undergoing surgical resection for lung cancer. BMC Cancer. 2017 Jul 31;17(1):508. doi: 10.1186/s12885-017-3479-y.

    PMID: 28760151DERIVED

MeSH Terms

Conditions

Lung NeoplasmsPulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sara Tenconi, Dr

    Azienda USL Reggio Emilia - IRCCS

    PRINCIPAL INVESTIGATOR

  • Stefania Fugazzaro, Dr

    Azienda USL Reggio Emilia - IRCCS

    STUDY DIRECTOR

  • Cristian Rapicetta, Dr

    Azienda USL Reggio Emilia - IRCCS

    STUDY CHAIR

  • Roberto Piro, Dr

    Azienda USL Reggio Emilia - IRCCS

    STUDY CHAIR

  • Besa Kopliku, Dr

    Azienda USL Reggio Emilia - IRCCS

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

April 1, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 11, 2025

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)