Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02978521
• Other study ID #: 016/028/ICI
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2016
• Est. completion date: December 12, 2025

Study information

• Verified date: January 2024
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: Oscar Arrieta
• Phone: 01 55 56280400
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 12, 2025
• Est. primary completion date: August 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Rehabilitation
• Quality of Life
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cancerología	Mexico Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function	Pulmonary function Maximal expiratory and inspiratory pressure units: cm H2O (measured with Jaeger spirometer)	After 12 sessions (6 weeks)
Secondary	Muscle mass	Muscle mass measured by body composition analysis of CT images using lumbar vertebra 3 (L3)	After 12 sessions (6 weeks)
Secondary	Inflammatory response	Quantification of: Interleukin (IL)-8, IL-1ß, 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	After 12 sessions (6 weeks)
Secondary	Exercise tolerance	6 minute walk test	After 12 sessions (6 weeks)
Secondary	Quality of Life in lung cancer	To determine the Quality of Life (QoL) of patients with lung cancer and its association with rehabilitation.; Application of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire, the EORTC QLQ-C30. It is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.; Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. It ranges in score from 0 to 100. A high scale score represents a higher response level.	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).
Secondary	Lung Cancer Quality of Life	Application of the "european organization for research and treatment of cancer quality of life questionnaire (QLQ)LC-13"	After 12 sessions (6 weeks)
Secondary	Anxiety and Depression	Hospital Anxiety and Depression Scale (HADS	After 12 sessions (6 weeks)