Lung CancerNCT04450719
Pulmonary and Extrapulmonary Impairments in Patients With Lung Cancer Awaiting Surgery
An observational study of Lung Cancer, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
To detect comparatively the extent to which physical impairments are observed in patients with lung cancer awaiting lung surgery, comparing exercise capacity, pulmonary functions, muscle strength, physical activity, dyspnea, fatigue and quality of life between the patients with lung cancer and healthy individuals was… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2018to 26 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty six patients with lung cancer and 21 healthy individuals were included in this study. All patients were referred from Gazi University, Faculty of Medicine, Department of Thoracic Surgery to Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. The patients with lung cancer who were decided to undergo lung surgery by thoracic surgeons were referred to the physiotherapist. Healthy volunteers were also recruited. Then, the patients were matched with healthy individuals according to statistically similarity of both age and gender.
Who may be able to join
- 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.
- being 18-80 years of age,
- willing to participate to the study,
- being individuals without known and diagnosed any chronic diseases.
Who cannot join
- 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.
- being current smokers,
- being ex-smokers (≥10 pack*years).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
Ankara, 06010
About this study
Official title: Exercise Capacity, Muscle Strength, Respiratory Characteristics, Physical Activity and Quality of Life in Patients With Lung Cancer Awaiting Surgery
To detect comparatively the extent to which physical impairments are observed in patients with lung cancer awaiting lung surgery, comparing exercise capacity, pulmonary functions, muscle strength, physical activity, dyspnea, fatigue and quality of life between the patients with lung cancer and healthy individuals was aimed in current study.
Read the 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.
- Conditions
- Lung Cancer
- Keywords
- lung cancer, walk test, pulmonary functions, muscle strength, physical activity, quality of life
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Group 2: Healthy individuals | Healthy individuals were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were performed in healthy individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test (6-MWT)
Exercise capacity was evaluated with this test according to the guidelines.
Measured: 10 minutes
Secondary outcomes (6)
Pulmonary function test
Dynamic lung volume was measured using a spirometry. Obtained values were represented in percentages.
Measured: 5 minutes
Respiratory strength test
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.
Measured: 10 minutes
Physical activity measurement
For this evaluation, a metabolic holter was used.
Measured: 3 days
Dyspnea scale
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).
Measured: 1 minute
Quality of life scale
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.
Measured: 2 minutes
Peripheral muscle strength test
A hand-held dynamometer was used to evaluate m. quadriceps femoris strength.
Measured: The test was performed during 10 minutes for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start10 Jul 2018
- Primary completion17 Jun 2019
- Study completion26 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Gülşah Barğı, PhD, Study chair, İzmir Democracy UniversityEce Baytok, MsC, Study chair, Gazi UniversityZeliha Çelik, MsC, Study chair, Gazi UniversityMerve Şatır Türk, MD, Study chair, Gazi UniversityAli Çelik, Prof. Dr., Study chair, Gazi Universityİsmail Cüneyt Kurul, Prof. Dr., Study chair, Gazi UniversityMeral Boşnak Güçlü, Prof. Dr., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450719
- Sponsor's protocol ID
- Gazi University 20
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.
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.
PubMed 30207593Jones 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.
PubMed 19482248Travers 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.
PubMed 17975124Cavalheri 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.
PubMed 26342839Pinson 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.
PubMed 9631365Granger 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.
PubMed 24360323Sullivan 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.
PubMed 1914100Wagner 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.
PubMed 18678625Solway 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.
PubMed 11157613Granger 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.
PubMed 25749346Laude 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.
PubMed 16439720Nomori 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.
PubMed 8737692Weiner 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.
PubMed 9081102Bower 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.
PubMed 25113839Fox 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.
PubMed 16955121
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capacity, Muscle Strength, Respiratory Characteristics, Physical Activity and Quality of Life in Patients With Lung Cancer Awaiting Surgery
- ClinicalTrials.gov ID
- NCT04450719
- Acronym / sponsor ID
- Gazi University 20
- Conditions
- Lung Cancer
- Keywords
- lung cancer, walk test, pulmonary functions, muscle strength, physical activity, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To detect comparatively the extent to which physical impairments are observed in patients with lung cancer awaiting lung surgery, comparing exercise capacity, pulmonary functions, muscle strength, physical activity, dyspnea, fatigue and quality of life between the patients with lung cancer and healthy individuals was aimed in current study.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Group 2: Healthy individuals | – | –Healthy individuals were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were performed in healthy individuals. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty six patients with lung cancer and 21 healthy individuals were included in this study. All patients were referred from Gazi University, Faculty of Medicine, Department of Thoracic Surgery to Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. The patients with lung cancer who were decided to undergo lung surgery by thoracic surgeons were referred to the physiotherapist. Healthy volunteers were also recruited. Then, the patients were matched with healthy individuals according to statistically similarity of both age and gender.
Key inclusion criteria (7 listed)
- 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.
- being 18-80 years of age,
Key exclusion criteria (6 listed)
- 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.
- being current smokers,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6-minute walk test (6-MWT)
Time frame: 10 minutes
Exercise capacity was evaluated with this test according to the guidelines.
6 secondary outcomes
Pulmonary function test
Time frame: 5 minutes
Respiratory strength test
Time frame: 10 minutes
Physical activity measurement
Time frame: 3 days
Dyspnea scale
Time frame: 1 minute
Quality of life scale
Time frame: 2 minutes
Peripheral muscle strength test
Time frame: The test was performed during 10 minutes for each participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Results publication: PubMed 30207593Bray 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.
- Results publication: PubMed 19482248Jones 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.
- Results publication: PubMed 17975124Travers 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.
- Results publication: PubMed 26342839Cavalheri 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.
- Results publication: PubMed 9631365Pinson 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.
- Results publication: PubMed 24360323Granger 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.
- Results publication: PubMed 1914100Sullivan 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.
- Results publication: PubMed 18678625Wagner 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.
- Results publication: PubMed 11157613Solway 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.
- Results publication: PubMed 25749346Granger 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.
- Results publication: PubMed 16439720Laude 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.
- Results publication: PubMed 8737692Nomori 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.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülşah Barğı, PhD study chair
İzmir Democracy University
Ece Baytok, MsC study chair
Gazi University
Zeliha Çelik, MsC study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (6-MWT) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04450719, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.