Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients

NCT02978521 | Recruiting DMC

• 1 other identifier: 016/028/ICI
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer (LC) is usually diagnosed in advanced stages and continues to be the leading cause of cancer related deaths worldwide. Cancer cachexia are frequent among patients with LC affecting up to 80% of patients with advanced stage disease, and it has been related with higher risk of complications, length of hospital stay, and worst overall survival. During cancer cachexia, both muscle and fat mass can be wasted, however, the loss of muscle mass has been associated to higher treatment related toxicity, loss of functional status, shorter progression free survival and overall survival in different types of cancer under various treatments. Hence, preservation of muscle mass and function should be an important focus of the multidisciplinary treatment of patients with LC. Pulmonary rehabilitation (PR) has been known to improve pulmonary function, reduce fatigue and improve exercise tolerance in patients with LC undergoing curative surgery. However, few studies have focused on the efficacy of PR on patients with advanced cancer undergoing palliative care with chemotherapy or targeted therapies.

Conditions

Pulmonary Rehabilitation; Sarcopenia; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Pulmonary function

  Pulmonary function Maximal expiratory and inspiratory pressure units: cm H2O (measured with Jaeger spirometer)

  After 12 sessions (6 weeks)

Secondary Outcomes (6)

• Muscle mass

  After 12 sessions (6 weeks)

• Inflammatory response

  After 12 sessions (6 weeks)

• Exercise tolerance

  After 12 sessions (6 weeks)

• Quality of Life in lung cancer

  the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire is applied before and after a follow-up after 12 sessions (6 weeks).

• Lung Cancer Quality of Life

  After 12 sessions (6 weeks)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients in the IG will be scheduled to receive Pulmonary Rehabilitation: 12 sessions (60 minutes approximately) over a period of 4-6 weeks (2-3 session/week). Sessions will progress as patients tolerance to exercise and will include breathing techniques, resistance training on ergometer and treadmill.

Other: Pulmonary rehabilitation

Control Group

NO INTERVENTION

CG will receive information and recommendations on physical activity

Interventions

Pulmonary rehabilitation OTHER

Session 1: ventilatory pattern training Session 2,3: ventilatory pattern + respiratory training with incentive spirometer Session 4-6: Sessions 1-3 training continues + training with Positive expiratory pressure device (Threshold PEP) and breathing trainer Threshold IMT) Sessions 7-9: Continue respiratory training + resistance training with RECK MOTOmed2 ergometer at a 30% intensity until 60% is achieved Session 10-12: Continue with previous training + treadmill training

Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of advanced non-small-cell lung cancer
• Good performance status (ECOG 0-1)
• Life expectancy \>12 weeks
• Eligible to receive treatment with chemotherapy or tyrosinkinase inhibitors
• Recent electrocardiogram without evidence of arrythmia

You may not qualify if:

• Symptomatic brain metastasis
• Uncontrolled pain (Visual Analog Scale \>5)
• Uncontrolled hypertension (\>140/100mmHg)
• Practice of regular moderate to intense physical activity at least 3 day/week
• Not residents of Mexico City or unable to attend to therapy sessions

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerología

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (14)

• Bruera E. ABC of palliative care. Anorexia, cachexia, and nutrition. BMJ. 1997 Nov 8;315(7117):1219-22. doi: 10.1136/bmj.315.7117.1219. No abstract available.

  PMID: 9393230 BACKGROUND

• Argiles JM, Alvarez B, Lopez-Soriano FJ. The metabolic basis of cancer cachexia. Med Res Rev. 1997 Sep;17(5):477-98. doi: 10.1002/(sici)1098-1128(199709)17:53.0.co;2-r. No abstract available.

  PMID: 9276862 BACKGROUND

• Blum D, Omlin A, Baracos VE, Solheim TS, Tan BH, Stone P, Kaasa S, Fearon K, Strasser F; European Palliative Care Research Collaborative. Cancer cachexia: a systematic literature review of items and domains associated with involuntary weight loss in cancer. Crit Rev Oncol Hematol. 2011 Oct;80(1):114-44. doi: 10.1016/j.critrevonc.2010.10.004. Epub 2011 Jan 8.

  PMID: 21216616 BACKGROUND

• Rhee CM, Kalantar-Zadeh K. Resistance exercise: an effective strategy to reverse muscle wasting in hemodialysis patients? J Cachexia Sarcopenia Muscle. 2014 Sep;5(3):177-80. doi: 10.1007/s13539-014-0160-z. Epub 2014 Aug 28.

  PMID: 25163460 BACKGROUND

• Ozalevli S, Ilgin D, Kul Karaali H, Bulac S, Akkoclu A. The effect of in-patient chest physiotherapy in lung cancer patients. Support Care Cancer. 2010 Mar;18(3):351-8. doi: 10.1007/s00520-009-0659-6. Epub 2009 May 28.

  PMID: 19471973 BACKGROUND

• Tarumi S, Yokomise H, Gotoh M, Kasai Y, Matsuura N, Chang SS, Go T. Pulmonary rehabilitation during induction chemoradiotherapy for lung cancer improves pulmonary function. J Thorac Cardiovasc Surg. 2015 Feb;149(2):569-73. doi: 10.1016/j.jtcvs.2014.09.123. Epub 2014 Oct 5.

  PMID: 25451483 BACKGROUND

• Mourtzakis M, Prado CM, Lieffers JR, Reiman T, McCargar LJ, Baracos VE. A practical and precise approach to quantification of body composition in cancer patients using computed tomography images acquired during routine care. Appl Physiol Nutr Metab. 2008 Oct;33(5):997-1006. doi: 10.1139/H08-075.

  PMID: 18923576 BACKGROUND

• Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6.

  PMID: 18539529 BACKGROUND

• Degner LF, Sloan JA. Symptom distress in newly diagnosed ambulatory cancer patients and as a predictor of survival in lung cancer. J Pain Symptom Manage. 1995 Aug;10(6):423-31. doi: 10.1016/0885-3924(95)00056-5.

  PMID: 7561224 BACKGROUND

• Stigt JA, Uil SM, van Riesen SJ, Simons FJ, Denekamp M, Shahin GM, Groen HJ. A randomized controlled trial of postthoracotomy pulmonary rehabilitation in patients with resectable lung cancer. J Thorac Oncol. 2013 Feb;8(2):214-21. doi: 10.1097/JTO.0b013e318279d52a.

  PMID: 23238118 BACKGROUND

• Rivas-Perez H, Nana-Sinkam P. Integrating pulmonary rehabilitation into the multidisciplinary management of lung cancer: a review. Respir Med. 2015 Apr;109(4):437-42. doi: 10.1016/j.rmed.2015.01.001. Epub 2015 Jan 22.

  PMID: 25641113 BACKGROUND

• Jastrzebski D, Maksymiak M, Kostorz S, Bezubka B, Osmanska I, Mlynczak T, Rutkowska A, Baczek Z, Ziora D, Kozielski J. Pulmonary Rehabilitation in Advanced Lung Cancer Patients During Chemotherapy. Adv Exp Med Biol. 2015;861:57-64. doi: 10.1007/5584_2015_134.

  PMID: 26017725 BACKGROUND

• Henke CC, Cabri J, Fricke L, Pankow W, Kandilakis G, Feyer PC, de Wit M. Strength and endurance training in the treatment of lung cancer patients in stages IIIA/IIIB/IV. Support Care Cancer. 2014 Jan;22(1):95-101. doi: 10.1007/s00520-013-1925-1. Epub 2013 Sep 1.

  PMID: 23995813 BACKGROUND

• Hwang CL, Yu CJ, Shih JY, Yang PC, Wu YT. Effects of exercise training on exercise capacity in patients with non-small cell lung cancer receiving targeted therapy. Support Care Cancer. 2012 Dec;20(12):3169-77. doi: 10.1007/s00520-012-1452-5. Epub 2012 Apr 14.

  PMID: 22526147 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Oscar Arrieta

  Head of Thoracic Oncology Unit

  STUDY DIRECTOR

Central Study Contacts

Oscar Arrieta

CONTACT

01 55 56280400

Diana Flores

CONTACT

01 55 56280400

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of the Thoracic Oncology Unit

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: December 1, 2016
• Study Start: August 5, 2016
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 12, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)