- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450719
Pulmonary and Extrapulmonary Impairments in Patients With Lung Cancer Awaiting Surgery
Exercise Capacity, Muscle Strength, Respiratory Characteristics, Physical Activity and Quality of Life in Patients With Lung Cancer Awaiting Surgery
Study Overview
Status
Conditions
Detailed Description
According to global cancer statistics, the most commonly diagnosing and the highest mortality rates belong to lung cancer. As known, patients with lung cancer suffer from many pathophysiological changes due to characteristics of the lung cancer and its cytotoxic treatments including chemotherapy and radiotherapy. Especially, these changes commonly occur in respiratory mechanics and gas exchange all of which resulted in pulmonary function impairment. Moreover, excessive weight loss, anemia, protein catabolism, muscle wasting, skeletal muscle atrophy and inhibition of muscle regeneration are observed in these patients in course of time.
The 6-minute walk test provides valuable and valid knowledge about exercise intolerance in diseases. As known, progressive decline in exercise capacity is commonly observed in patients with lung cancer. The loss of muscle mass also happens not only peripheral muscle but also respiratory muscles in patients with lung cancer. Based on the limited studies regarding patients with lung cancer, weakness in respiratory muscles before surgery has been demonstrated. Furthermore, these patients experience fatigue and dyspnea perceptions all of which increase disease burden and afflict quality of life.
According to the results of a study compared the patients with lung cancer before surgery and healthy individuals, the patients are less physically active than healthy individuals. Moreover, at the diagnosis stage, the patients have worse quadriceps muscle strength, nutritional status, mood and quality of life compared to others. After six months, the patients experience decreases in physical activity, 6-minute walk test distance, and muscle strength and worsening symptoms following chemotherapy, radiotherapy and/or surgery. On the other hand, it could not be clearly demonstrated in the literature to the amount of impairments of pulmonary function and respiratory muscle strength compared to healthy individuals.
To reveal aforementioned impairments in patients with lung cancer before surgery is of importance in terms of being helpful in both determining the protective rehabilitation program and also reducing the disease burden and other possible factors in lung cancer. Therefore, the aim of the current study was to investigate the differences in exercise capacity, pulmonary functions, respiratory and peripheral muscle strength, physical activity level, dyspnea, fatigue and quality of life between the patients with lung cancer before lung surgery and gender and age-matched healthy individuals.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey, 06010
- Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for patients:
- being between ages of 18 and 80,
- being a candidate for lung surgery due to lung cancer diagnosis,
- being able to walk,
- receiving optimal medical therapy.
Exclusion Criteria for patients:
- having health problems such as cooperation,
- having orthopedic or neurological disease that limit the walking ability and physical activity,
- having comorbidities such as uncontrolled diabetes mellitus, heart failure, atrial fibrillation and/or hypertension, acute infections,
- having myocardial infarction in the last six months.
Inclusion Criteria for healthy individuals:
- being 18-80 years of age,
- willing to participate to the study,
- being individuals without known and diagnosed any chronic diseases.
Exclusion Criteria for healthy individuals:
- being current smokers,
- being ex-smokers (≥10 pack*years).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1: Patients with lung cancer
Exercise capacity [6-minute walk test (6-MWT)], pulmonary functions [spirometry], respiratory [maximal inspiratory and expiratory pressures (MIP-MEP), mouth pressure device] and peripheral muscle strength [dynamometer], physical activity level [metabolic holter], dyspnea [Modified Medical Research Council dyspnea scale (MMRC)] and quality of life [European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)] were evaluated in patients with lung cancer.
Vital signs, dyspnea and fatigue perception [Modified Borg Scale] were recorded as pre-post measurements of 6-MWT.
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Group 2: Healthy individuals
Healthy individuals were selected from individuals without known and diagnosed any chronic diseases.
Similar measurements were performed in healthy individuals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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6-minute walk test (6-MWT)
Time Frame: 10 minutes
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Exercise capacity was evaluated with this test according to the guidelines.
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10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Physical activity measurement
Time Frame: 3 days
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For this evaluation, a metabolic holter was used.
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3 days
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Pulmonary function test
Time Frame: 5 minutes
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Dynamic lung volume was measured using a spirometry.
Obtained values were represented in percentages.
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5 minutes
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Respiratory strength test
Time Frame: 10 minutes
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Respiratory muscle weakness was detected using volitional measurements of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) via a portable mouth pressure device based on guidelines.
Both MIP and MEP were represented with same units as cmH2O and percentages.
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10 minutes
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Dyspnea scale
Time Frame: 1 minute
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The Modified Medical Research Council (MMRC) dyspnea scale was used.
Dyspnea levels are categorized between 0 (dyspnea only with strenuous exercise) and 4 (too breathless to leave the house or when dressing/undressing).
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1 minute
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Quality of life scale
Time Frame: 2 minutes
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European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version3.0
(EORTC QLQ-C30) was used to evaluate aspects of quality of life impairment.
Self-administered questionnaire incorporates five functional scales including social functioning subscale, three symptom scales including fatigue subscale, a global health status and several single items.
All item scores are transformed to 0-100.
Higher values represent higher functional/healthy level in functional scales, a higher quality of life level in global health status and increased presence of symptoms in symptom scales.
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2 minutes
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Peripheral muscle strength test
Time Frame: The test was performed during 10 minutes for each participant.
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A hand-held dynamometer was used to evaluate m. quadriceps femoris strength.
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The test was performed during 10 minutes for each participant.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ece BAYTOK, MsC, Gazi University
- Study Chair: Zeliha Çelik, MsC, Gazi University
- Study Chair: Gülşah Barğı, PhD, Izmir Democracy University
- Study Chair: Merve Şatır Türk, MD, Gazi University
- Study Chair: Ali Çelik, Prof. Dr., Gazi University
- Study Chair: İsmail Cüneyt Kurul, Prof. Dr., Gazi University
Publications and helpful links
General Publications
- Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.
- Jones LW, Eves ND, Haykowsky M, Freedland SJ, Mackey JR. Exercise intolerance in cancer and the role of exercise therapy to reverse dysfunction. Lancet Oncol. 2009 Jun;10(6):598-605. doi: 10.1016/S1470-2045(09)70031-2.
- Cavalheri V, Jenkins S, Cecins N, Gain K, Phillips M, Sanders LH, Hill K. Impairments after curative intent treatment for non-small cell lung cancer: a comparison with age and gender-matched healthy controls. Respir Med. 2015 Oct;109(10):1332-9. doi: 10.1016/j.rmed.2015.08.015. Epub 2015 Aug 29.
- Travers J, Dudgeon DJ, Amjadi K, McBride I, Dillon K, Laveneziana P, Ofir D, Webb KA, O'Donnell DE. Mechanisms of exertional dyspnea in patients with cancer. J Appl Physiol (1985). 2008 Jan;104(1):57-66. doi: 10.1152/japplphysiol.00653.2007. Epub 2007 Nov 1.
- Pinson P, Klastersky J. The value of lung function measurements for the assessment of chemotherapy in lung cancer patients. Lung Cancer. 1998 Mar;19(3):179-84. doi: 10.1016/s0169-5002(97)00094-9.
- Granger CL, McDonald CF, Irving L, Clark RA, Gough K, Murnane A, Mileshkin L, Krishnasamy M, Denehy L. Low physical activity levels and functional decline in individuals with lung cancer. Lung Cancer. 2014 Feb;83(2):292-9. doi: 10.1016/j.lungcan.2013.11.014. Epub 2013 Nov 26.
- Sullivan MJ, Green HJ, Cobb FR. Altered skeletal muscle metabolic response to exercise in chronic heart failure. Relation to skeletal muscle aerobic enzyme activity. Circulation. 1991 Oct;84(4):1597-607. doi: 10.1161/01.cir.84.4.1597.
- Wagner PD. The major limitation to exercise performance in COPD is inadequate energy supply to the respiratory and locomotor muscles vs. lower limb muscle dysfunction vs. dynamic hyperinflation. The real cause of exercise limitation in COPD. J Appl Physiol (1985). 2008 Aug;105(2):758. doi: 10.1152/japplphysiol.90336.2008c. No abstract available.
- Solway S, Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001 Jan;119(1):256-70. doi: 10.1378/chest.119.1.256.
- Granger CL, Holland AE, Gordon IR, Denehy L. Minimal important difference of the 6-minute walk distance in lung cancer. Chron Respir Dis. 2015 May;12(2):146-54. doi: 10.1177/1479972315575715. Epub 2015 Mar 6.
- Laude EA, Duffy NC, Baveystock C, Dougill B, Campbell MJ, Lawson R, Jones PW, Calverley PM. The effect of helium and oxygen on exercise performance in chronic obstructive pulmonary disease: a randomized crossover trial. Am J Respir Crit Care Med. 2006 Apr 15;173(8):865-70. doi: 10.1164/rccm.200506-925OC. Epub 2006 Jan 26.
- Nomori H, Horio H, Fuyuno G, Kobayashi R, Yashima H. Respiratory muscle strength after lung resection with special reference to age and procedures of thoracotomy. Eur J Cardiothorac Surg. 1996;10(5):352-8. doi: 10.1016/s1010-7940(96)80094-7.
- Weiner P, Man A, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D, Greiff Y. The effect of incentive spirometry and inspiratory muscle training on pulmonary function after lung resection. J Thorac Cardiovasc Surg. 1997 Mar;113(3):552-7. doi: 10.1016/S0022-5223(97)70370-2.
- Bower JE. Cancer-related fatigue--mechanisms, risk factors, and treatments. Nat Rev Clin Oncol. 2014 Oct;11(10):597-609. doi: 10.1038/nrclinonc.2014.127. Epub 2014 Aug 12.
- Fox SW, Lyon DE. Symptom clusters and quality of life in survivors of lung cancer. Oncol Nurs Forum. 2006 Sep 1;33(5):931-6. doi: 10.1188/06.ONF.931-936.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gazi University 20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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