Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients

Overview

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.

Full Title of Study: “Effect of a Pulmonary Rehabilitation Program on Skeletal Muscle Mass, Pulmonary Function, Inflammatory Response and Overall Survival on Patients Diagnosed With Non-small-cell Advanced Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2018

Detailed Description

The main objective of this study is to determine the effects of a pulmonary rehabilitation program on the pulmonary function and muscle mass. Moreover, the effects on exercise tolerance, inflammatory response, quality of live and overall survival will be explored.

Patients will be randomized into intervention group (IG) or control group (CG). Patients in the IG will be scheduled to receive 12 sessions of PR over a period of 4-6 weeks (2-3 session/week). CG will receive information and recommendations on physical activity. Both groups will receive nutritional assessment and intervention as needed.

Interventions

  • Other: Pulmonary rehabilitation
    • 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

Arms, Groups and Cohorts

  • Experimental: Intervention Group
    • 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.
  • No Intervention: Control Group
    • CG will receive information and recommendations on physical activity

Clinical Trial Outcome Measures

Primary Measures

  • Pulmonary function
    • Time Frame: After 12 sessions (6 weeks)
    • Pulmonary function Maximal expiratory and inspiratory pressure units: cm H2O (measured with Jaeger spirometer)

Secondary Measures

  • Muscle mass
    • Time Frame: After 12 sessions (6 weeks)
    • Muscle mass measured by body composition analysis of CT images using lumbar vertebra 3 (L3)
  • Inflammatory response
    • Time Frame: After 12 sessions (6 weeks)
    • Quantification of: Interleukin (IL)-8, IL-1β, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF) (Human Inflammatory Cytokine Kit Becton, Dickinson and Company (BD)™ Cytometric Bead Array) Units: pg/ml
  • Exercise tolerance
    • Time Frame: After 12 sessions (6 weeks)
    • 6 minute walk test
  • Quality of Life
    • Time Frame: After 12 sessions (6 weeks)
    • Application of the “european organization for research and treatment of cancer quality of life questionnaire (QLQ)-C30
  • Lung Cancer Quality of Life
    • Time Frame: After 12 sessions (6 weeks)
    • Application of the “european organization for research and treatment of cancer quality of life questionnaire (QLQ)LC-13″
  • Anxiety and Depression
    • Time Frame: After 12 sessions (6 weeks)
    • Hospital Anxiety and Depression Scale (HADS

Participating in This Clinical Trial

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto Nacional de Cancerologia de Mexico
  • Provider of Information About this Clinical Study
    • Principal Investigator: Oscar Gerardo Arrieta Rodríguez MD, Principal Investigator, Head of the Thoracic Oncology Unit – Instituto Nacional de Cancerologia de Mexico
  • Overall Official(s)
    • Oscar Arrieta, Study Director, Head of Thoracic Oncology Unit
  • Overall Contact(s)
    • Oscar Arrieta, 01 55 56280400

References

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Argilés JM, Alvarez B, López-Soriano FJ. The metabolic basis of cancer cachexia. Med Res Rev. 1997 Sep;17(5):477-98. Review.

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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.

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.

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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. Review.

Jastrzębski D, Maksymiak M, Kostorz S, Bezubka B, Osmanska I, Młynczak 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.

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.

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