Lung CancerNCT03838757
Maximal Exercise Capacity and Extra-pulmonary Characteristics in Patients With Lung Cancer With Complete Remission .
An observational study of Lung Cancer, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
While lung cancer are rare disease in the early 20th century, its incidence increased in parallel with the increase in smoking habits. It is the most common type of cancer in the world. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2015to Feb 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 patients with lung cancer were included in the patients group and 20 healthy individuals were included in the control group
Who may be able to join
- Patients with; Diagnosed with lung cancer Stage 1, stage 2 and stage 3 patients in lung cancer patients Clinically stable and Under standard medication patients were included.
Who cannot join
- Patients with Metastasis Orthopedic and neurological problems Acute infection Non-co-operable
- Healthy Subjects with Any diagnosed disease were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Yenimahalle
About this study
Official title: Maximal Exercise Capacity, Extra-pulmonary Characteristics and Physical Activity Levels in Patients With Lung Cancer With Complete Remission .
While lung cancer are rare disease in the early 20th century, its incidence increased in parallel with the increase in smoking habits. It is the most common type of cancer in the world. Despite advances in the efficacy of chemotherapy and radiotherapy regimens, surgical resection is the most effective curative treatment modality to improve survival in non-small cell lung cancer. Pulmonary resection candidates are selected according to not only tumor type and stage, but also functional status, exercise capacity, underlying lung disorders and health-related quality of life assessments. Patients with lung cancer often have lung and heart comorbidities that affect the outcome of the outcome measures and restricts cancer treatment options. In patients with lung cancer, shortness of breath, physical inactivity, weakness in peripheral muscles and exercise intolerance are described. Pulmonary rehabilitation is a multidisciplinary treatment designed to improve exercise capacity, functional status, health-related quality of life and to reduce the attenuation of chronic shortness of breath and fatigue in patients with chronic lung problems.
In literature, the effect of surgery in patients with lung cancer on postoperative respiratory muscle strength is not clear. There is no study investigating the effect of chemotherapy and radiotherapy on respiratory muscle strength. For these reasons, the aim of the study was to evaluate the curative period of non-small cell lung cancer patients with reliability and validity assessment methods. The hypothesis of our study was; when compared with patients with lung cancer and healthy individuals, exercise capacity, respiratory and peripheral muscle strength, physical activity levels, sleep and quality of life of lung cancer patients are reduced; dyspnoea, fatigue, depression, cough and pain levels increase.
Read the detailed description
According to sample size calculation 20 lung with complete remission cancer patients and 20 healthy individuals were included in the study. Cross-sectional observational research. The demographic, physical and physiological characteristics were recorded from the patient files. Exercise capacity (using cardiopulmonary exercise testing), physical activity, pulmonary functions, respiratory and peripheral muscle strength, dyspnea and fatigue perception, depression, cough, pain and quality of life were evaluated. Primary outcome measurement is maximal exercise capacity. Secondary outcomes are respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, depression, cough, pain and quality of life.
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Exercise capacity, Cardiopulmonary exercise test, Respiratory muscle strength, Physical activity, Pulmonary functions, Peripheral Muscle Strength, Quality of life, Sleep of quality, Dyspnea, Depression, Fatigue, Cough
- Medical subject headings
- Lung Neoplasms, Motor Activity, Dyspnea, Depression, Fatigue, Cough
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 |
|---|---|---|
| Patients | Maximal exercise capacity was assessed using cardiopulmonary exercise testing (CPET), exercise capacity six minute walk test, physical activity multi-sensor activity monitor, pulmonary function spirometry, respiratory muscle strength mouth pressure device, peripheral muscle strength hand held dynamometer, dyspnea Modified Medical Research Council Dyspnea Scale (MMRC), fatigue Fatigue Severity Scale, quality of life The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) and Functional Assessment of Cancer Therapy - Lung cancer quality of life questionnaire (FACT-L), depression Montgomery Asberg Depression scale, sleep of quality Pittsburgh Sleep Quality index and cough using Leicester Cough Questionnaire were evaluated. | |
| Healthy controls | Maximal exercise capacity was assessed using cardiopulmonary exercise testing (CPET), exercise capacity six minute walk test, physical activity multi-sensor activity monitor, pulmonary function spirometry, respiratory muscle strength mouth pressure device, peripheral muscle strength hand held dynamometer, dyspnea Modified Medical Research Council Dyspnea Scale (MMRC), fatigue Fatigue Severity Scale, quality of life The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) and Functional Assessment of Cancer Therapy - Lung cancer quality of life questionnaire (FACT-L), depression Montgomery Asberg Depression scale, sleep of quality Pittsburgh Sleep Quality index and cough using Leicester Cough Questionnaire were evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal exercise capacity
Cardiopulmonary exercise testing (Oxygen consumption measurement during test).
Measured: Second day
Secondary outcomes (12)
Functional exercise capacity
The six-minute walking test (6-MWT) was used to evaluate submaximal exercise capacity.
Measured: First day
Physical activity
Physical activity will be evaluated multi sensor activity monitor for 2 consecutive days.
Measured: First day
Pulmonary function test
This test was evaluated using a spirometry by which is evaluated dynamic lung functions expressed as percentages of expected values.
Measured: First day
Inspiratory and Expiratory muscle strength (MIP, MEP)
Respiratory muscle strength was evaluated with a mouth pressure device
Measured: First day
Peripheral muscle strength
Peripheral muscle strength was evaluated with a hand-held dynamometer.
Measured: First day
Dyspnea
The severity of dyspnea during daily living activities was evaluated using the Modified Medical Research Council (MMRC) dyspnea scale. Dyspnea is graded as follows: zero (dyspnea only with strenuous exercise), one (dyspnea when hurrying or walking up a slight hill), two (walks slower than people of the same age due to dyspnea or having to stop for breath when walking at own pace), three (stops for breath after walking 100 yards or after a few minutes) and four (too dyspneic to leave house or breathless when dressing). The minimal clinically important difference (MCID) is 1 unit for the MMRC dyspnea scale.
Measured: First day
Fatigue Severity
The Turkish version of Fatigue Severity Scale, which is a valid and reliable test, was performed to the recipients for evaluation of fatigue severity. Self-administered questionnaire is comprised of nine questions. The average score is identified on seven-point scale. Patients select a number from 1 to 7 for each 9 questions which demonstrates from strong disagreement to strong agreement, respectively. The cut-off score for fatigue severity is 36 according to this scale, if the total score obtained from this scale is higher than 36, the recipient is defined as severe fatigue.
Measured: First day
Life Quality
Quality of life was measured using Turkish version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 (EORTCQLQ) which is widely used as health related quality of life questionnaire in cancer patients. The cancer-specific questionnaire has 30 questions and incorporates five functional scales, three symptom scales, a global health status and several single items. All item scores are transformed to 0-100. Higher values indicate higher functional/healthy level in functional scales, a higher quality of life level in global health status and increased symptoms in symptom scales.
Measured: First day
Depression
Montgomery Asberg Depression Rating Scale (MADRS) (Turkish version of scale) This assessment tool contains 10 items with a score from 0 to 6, thus the maximum score is 60. A higher score indicates a more severe depression.
Measured: First day
Sleep of quality
Sleep quality of the individuals was evaluated with the Turkish version of Pittsburgh Sleep Quality Index. It is an individual evaluation scale that evaluates sleep quality and sleep disturbance in the last one month period.
Measured: First day
Cough
The Turkish version of the Leicester Cough Scale (LÖQ) was used to assess the health-related quality of life of individuals with chronic cough. The scale evaluates chronic cough consisting of 19 items, including physical (8 items), psychosocial (7 items) and social (4 items) subsections. Each item is scored between 1 (always) and 7 (never). The total score is 3-21 points. The high scores obtained from this questionnaire, which evaluates the effect of the symptoms that have been going on for the last two weeks, show less impact on cough and lower scores indicate more impact.
Measured: First day
Life Quality
Functional Assessment of Cancer Therapy - Lung cancer Quality of life questionnaire (Turkish version) is used to assess the quality of life of lung cancer patients from many cultures all over the world. It is an individual applied scale and consists of 36 questions specific to lung cancer. Body is a scale consisting of 5 subsections including status, social life and family situation, emotional state, activity status and other concerns.
Measured: Second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start31 Dec 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Other
- Enrolment
- 40 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
- Zeynep Pelin Dündar, MSc, Study chair, Gazi UniversityMeral Boşnak Güçlü, Assoc. Prof, Study director, Gazi UniversityAydın Çiltaş, MD, Principal investigator, Gebze Medical Park HospitalMustafa Benekli, MD, Principal investigator, Cukurambar/Ankara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838757
- Sponsor's protocol ID
- Gaziuniversity13
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26342839Granger CL, Denehy L, Parry SM, Martin J, Dimitriadis T, Sorohan M, Irving L. Which field walking test should be used to assess functional exercise capacity in lung cancer? An observational study. BMC Pulm Med. 2015 Aug 12;15:89. doi: 10.1186/s12890-015-0075-2.
PubMed 26264470Cavalheri V, Jenkins S, Cecins N, Gain K, Hill K. Comparison of the six-minute walk test with a cycle-based cardiopulmonary exercise test in people following curative intent treatment for non-small cell lung cancer. Chron Respir Dis. 2016 May;13(2):118-27. doi: 10.1177/1479972316631137. Epub 2016 Feb 11.
PubMed 26869579Granger CL, Parry SM, Edbrooke L, Denehy L. Deterioration in physical activity and function differs according to treatment type in non-small cell lung cancer - future directions for physiotherapy management. Physiotherapy. 2016 Sep;102(3):256-63. doi: 10.1016/j.physio.2015.10.007. Epub 2015 Oct 23.
PubMed 26597694Arbane G, Douiri A, Hart N, Hopkinson NS, Singh S, Speed C, Valladares B, Garrod R. Effect of postoperative physical training on activity after curative surgery for non-small cell lung cancer: a multicentre randomised controlled trial. Physiotherapy. 2014 Jun;100(2):100-7. doi: 10.1016/j.physio.2013.12.002. Epub 2014 Feb 12.
PubMed 24703523Hashmi A, Baciewicz FA Jr, Soubani AO, Gadgeel SM. Preoperative pulmonary rehabilitation for marginal-function lung cancer patients. Asian Cardiovasc Thorac Ann. 2017 Jan;25(1):47-51. doi: 10.1177/0218492316683757. Epub 2016 Dec 5.
PubMed 27913735
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Exercise Capacity, Extra-pulmonary Characteristics and Physical Activity Levels in Patients With Lung Cancer With Complete Remission .
- ClinicalTrials.gov ID
- NCT03838757
- Acronym / sponsor ID
- Gaziuniversity13
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Exercise capacity, Cardiopulmonary exercise test, Respiratory muscle strength, Physical activity, Pulmonary functions, Peripheral Muscle Strength, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 31 Dec 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 12 Feb 2019 (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.
While lung cancer are rare disease in the early 20th century, its incidence increased in parallel with the increase in smoking habits. It is the most common type of cancer in the world. Despite advances in the efficacy of chemotherapy and radiotherapy regimens, surgical resection is the most effective curative treatment modality to improve survival in non-small cell lung cancer. Pulmonary resection candidates are selected according to not only tumor type and stage, but also functional status, exercise capacity, underlying lung disorders and health-related quality of life assessments. Patients with lung cancer often have lung and heart comorbidities that affect the outcome of the outcome measures and restricts cancer treatment options. In patients with lung cancer, shortness of breath, physical inactivity, weakness in peripheral muscles and exercise intolerance are described. Pulmonary rehabilitation is a multidisciplinary treatment designed to improve exercise capacity, functional status, health-related quality of life and to reduce the attenuation of chronic shortness of breath and fatigue in patients with chronic lung problems.
In literature, the effect of surgery in patients with lung cancer on postoperative respiratory muscle strength is not clear. There is no study investigating the effect of chemotherapy and radiotherapy on respiratory muscle strength. For these reasons, the aim of the study was to evaluate the curative period of non-small cell lung cancer patients with reliability and validity assessment methods. The hypothesis of our study was; when compared with patients with lung cancer and healthy individuals, exercise capacity, respiratory and peripheral muscle strength, physical activity levels, sleep and quality of life of lung cancer patients are reduced; dyspnoea, fatigue, depression, cough and pain levels increase.
Detailed description
According to sample size calculation 20 lung with complete remission cancer patients and 20 healthy individuals were included in the study. Cross-sectional observational research. The demographic, physical and physiological characteristics were recorded from the patient files. Exercise capacity (using cardiopulmonary exercise testing), physical activity, pulmonary functions, respiratory and peripheral muscle strength, dyspnea and fatigue perception, depression, cough, pain and quality of life were evaluated. Primary outcome measurement is maximal exercise capacity. Secondary outcomes are respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, depression, cough, pain and quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Maximal exercise capacity was assessed using cardiopulmonary exercise testing (CPET), exercise capacity six minute walk test, physical activity multi-sensor activity monitor, pulmonary function spirometry, respiratory muscle strength mouth pressure device, peripheral muscle strength hand held dynamometer, dyspnea Modified Medical Research Council Dyspnea Scale (MMRC), fatigue Fatigue Severity Scale, quality of life The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) and Functional Assessment of Cancer Therapy - Lung cancer quality of life questionnaire (FACT-L), depression Montgomery Asberg Depression scale, sleep of quality Pittsburgh Sleep Quality index and cough using Leicester Cough Questionnaire were evaluated. |
| Healthy controls | – | –Maximal exercise capacity was assessed using cardiopulmonary exercise testing (CPET), exercise capacity six minute walk test, physical activity multi-sensor activity monitor, pulmonary function spirometry, respiratory muscle strength mouth pressure device, peripheral muscle strength hand held dynamometer, dyspnea Modified Medical Research Council Dyspnea Scale (MMRC), fatigue Fatigue Severity Scale, quality of life The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) and Functional Assessment of Cancer Therapy - Lung cancer quality of life questionnaire (FACT-L), depression Montgomery Asberg Depression scale, sleep of quality Pittsburgh Sleep Quality index and cough using Leicester Cough Questionnaire were evaluated. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with lung cancer were included in the patients group and 20 healthy individuals were included in the control group
Key inclusion criteria (1 listed)
- Patients with; Diagnosed with lung cancer Stage 1, stage 2 and stage 3 patients in lung cancer patients Clinically stable and Under standard medication patients were included.
Key exclusion criteria (2 listed)
- Patients with Metastasis Orthopedic and neurological problems Acute infection Non-co-operable
- Healthy Subjects with Any diagnosed disease were excluded.
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
Maximal exercise capacity
Time frame: Second day
Cardiopulmonary exercise testing (Oxygen consumption measurement during test).
12 secondary outcomes
Functional exercise capacity
Time frame: First day
Physical activity
Time frame: First day
Pulmonary function test
Time frame: First day
Inspiratory and Expiratory muscle strength (MIP, MEP)
Time frame: First day
Peripheral muscle strength
Time frame: First day
Dyspnea
Time frame: First day
Fatigue Severity
Time frame: First day
Life Quality
Time frame: First day
Depression
Time frame: First day
Sleep of quality
Time frame: First day
Cough
Time frame: First day
Life Quality
Time frame: Second day
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 12 Feb 2019.
- 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 26264470Granger CL, Denehy L, Parry SM, Martin J, Dimitriadis T, Sorohan M, Irving L. Which field walking test should be used to assess functional exercise capacity in lung cancer? An observational study. BMC Pulm Med. 2015 Aug 12;15:89. doi: 10.1186/s12890-015-0075-2.
- Results publication: PubMed 26869579Cavalheri V, Jenkins S, Cecins N, Gain K, Hill K. Comparison of the six-minute walk test with a cycle-based cardiopulmonary exercise test in people following curative intent treatment for non-small cell lung cancer. Chron Respir Dis. 2016 May;13(2):118-27. doi: 10.1177/1479972316631137. Epub 2016 Feb 11.
- Results publication: PubMed 26597694Granger CL, Parry SM, Edbrooke L, Denehy L. Deterioration in physical activity and function differs according to treatment type in non-small cell lung cancer - future directions for physiotherapy management. Physiotherapy. 2016 Sep;102(3):256-63. doi: 10.1016/j.physio.2015.10.007. Epub 2015 Oct 23.
- Results publication: PubMed 24703523Arbane G, Douiri A, Hart N, Hopkinson NS, Singh S, Speed C, Valladares B, Garrod R. Effect of postoperative physical training on activity after curative surgery for non-small cell lung cancer: a multicentre randomised controlled trial. Physiotherapy. 2014 Jun;100(2):100-7. doi: 10.1016/j.physio.2013.12.002. Epub 2014 Feb 12.
- Results publication: PubMed 27913735Hashmi A, Baciewicz FA Jr, Soubani AO, Gadgeel SM. Preoperative pulmonary rehabilitation for marginal-function lung cancer patients. Asian Cardiovasc Thorac Ann. 2017 Jan;25(1):47-51. doi: 10.1177/0218492316683757. Epub 2016 Dec 5.
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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.
Zeynep Pelin Dündar, MSc study chair
Gazi University
Meral Boşnak Güçlü, Assoc. Prof study director
Gazi University
Aydın Çiltaş, MD principal investigator
Gebze Medical Park Hospital
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 1 inclusion and 2 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 12 Feb 2019. 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?
Maximal exercise capacity (time frame: Second day). 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 NCT03838757, which also lists 6 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 12 Feb 2019.