Lung CancerNCT05320458
Pulmonary Rehabılıtatıon Wıth Non-Small Lung Cancer
A study testing Pulmonary Rehabilitation in people with Lung Cancer and Lung Cancer, Small Cell, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effects of pulmonary rehabilitation on respiratory tests and quality of life in patients with early and locally advanced NSCLC who received chemotherapy regardless of whether the investigators had undergone surgical treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lung Cancer, Lung Cancer, Small Cell
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2022to 2 Sep 2022
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65, must be in remission.
- Surgery, adjuvant chemotherapy and radiotherapy processes must be completed.
Who cannot join
- Those with suspected pregnancy
- Diabetes mellitus diagnosis
- Patients in the metastatic period
- Patients with a diagnosis of acute/chronic infection were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Rehabılıtatıon After Chemotherapy In Patıents Wıth Non-Small Lung Cancer
The aim of our study is to investigate the effects of pulmonary rehabilitation on respiratory tests and quality of life in patients with early and locally advanced NSCLC who received chemotherapy regardless of whether the investigators had undergone surgical treatment.
Read the detailed description
Patients with lung cancer often have concomitant lung and heart comorbidities that limit their cancer treatment options. For example, in the last prevalence study that included patients with newly diagnosed lung cancer, 73% of whom were men and 53% were women, there was clinically significant COPD. This patient population has shortness of breath, decreased physical capacity, low muscle condiction, and poor exercise tolerance.
Pulmonary rehabilitation is an intervention that has a scientific basis and is used systematically, aiming to optimize individual daily functions and health-related quality of life in patients with morbidity due to chronic diseases measured by clinical or physiological methods.
The effectiveness of pulmonary rehabilitation is well known in the treatment of patients with COPD and in the perioperative lung transplant preparation period. Studies lead to a significant increase in preoperative pulmonary rehabilitation exercise capacity, dyspnea and health-related quality of life.
The aim of our study is to investigate the effects of pulmonary rehabilitation on respiratory tests and quality of life in patients with early and locally advanced NSCLC who received chemotherapy regardless of whether the investigators had undergone surgical treatment.
This study was conducted with outpatients who were diagnosed with small cell lung cancer between 2021-2022, who were approved by the oncologist and physical therapist to participate in a physiotherapy and rehabilitation program. Permission for the study was obtained from the Non-Interventional Local Ethics Committee (decision dated 20.11.2018 and numbered 2018/34). The study was conducted in accordance with the Helsinki Declaration of Patient Rights. Individuals were informed about the study and a written informed consent form was signed by the individuals who volunteered to participate.
Participants Thirty patients aged 18-65 years in remission were included in the study. Surgery, adjuvant chemotherapy and radiotherapy processes of all patients included in the study were completed. Patients with suspected pregnancy, diagnosis of diabetes mellitus, patients in metastatic period, and patients with acute/chronic infection were excluded from the study.
Evaluation The patients' age, gender, height and body weight, medical history and family history information, education status, income level, smoking (pack/year), place of residence, admission to the emergency department in the last year, number of hospital admissions and hospitalizations, and medication used The information was recorded from the patients and their files. Participation of individuals in regular physical activity was questioned. In addition, pre- and post-treatment pain was evaluated using the visual analog scale (VAS).
The evaluations applied to the patients in our study;
- Posture Analysis
- Normal Joint Movement and Evaluation of Muscle Shortness
- Muscle Test
- Six Minute Walking Test
- Physical Activity Level
- Dyspnea Severity
- Quality of Life
- Fatigue Evaluation
Applied Treatments;
- Respiratory Exercises
- Walking Training
- Aerobic exercise training
- Conditions
- Lung Cancer, Lung Cancer, Small Cell
- Being tested
- Pulmonary Rehabilitation
- Keywords
- Lung Cancer, Pulmonary Rehabilitation, Aerobic Exercise, Physiotherapy and Rehabilitation, Oncological Rehabilitation
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
1-Pulmonary Rehabilitation: Pulmonary rehabilitation program was applied at 40-60% of submaximal heart rate, 3 days a week for a total of 8 weeks. Diaphragmatic breathing, pursed lip breathing and segmental breathing exercises were practiced with the patients in the company of a physiotherapist. Walking and aerobic exercise training was given.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation | Experimental | Pulmonary rehabilitation program will be applied 3 days a week at 40-60% of submaximal heart rate for a total of 8 weeks. Diaphragmatic breathing, pursed lips and segmental breathing exercises will be applied to the patients in the presence of a physiotherapist. Walking and aerobic exercise training will be given. Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chance from baseline in posture analysis score
Posture score is going to be assess by posture analysis form to determine change from baseline.
Measured: 8 week
Secondary outcomes (1)
Physical Activity Level
Physical Activity is going to be assess by Physical Activity Questionnaire to determine change from baseline.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start2 May 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion2 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group 30 individuals were included in the study. Surgery, adjuvant chemotherapy and radiotherapy processes of all patients included in the study were completed. Patients between the ages of 18-65 and in remission period were included in the study. Patients with suspected pregnancy, diabetes mellitus, metastatic patients, and patients with acute and chronic infections were excluded from the study.
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kardelen HATIMOĞULLARI, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320458
- Sponsor's protocol ID
- 2018/09
- Status last verified
- Apr 2022
- First submitted
- 25 Feb 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabılıtatıon After Chemotherapy In Patıents Wıth Non-Small Lung Cancer
- ClinicalTrials.gov ID
- NCT05320458
- Acronym / sponsor ID
- 2018/09
- Conditions
- Lung Cancer, Lung Cancer, Small Cell
- Keywords
- Lung Cancer, Pulmonary Rehabilitation, Aerobic Exercise, Physiotherapy and Rehabilitation, Oncological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 2 Sep 2022 (estimated)
- First posted
- 11 Apr 2022 (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.
The aim of our study is to investigate the effects of pulmonary rehabilitation on respiratory tests and quality of life in patients with early and locally advanced NSCLC who received chemotherapy regardless of whether the investigators had undergone surgical treatment.
Detailed description
Patients with lung cancer often have concomitant lung and heart comorbidities that limit their cancer treatment options. For example, in the last prevalence study that included patients with newly diagnosed lung cancer, 73% of whom were men and 53% were women, there was clinically significant COPD. This patient population has shortness of breath, decreased physical capacity, low muscle condiction, and poor exercise tolerance.
Pulmonary rehabilitation is an intervention that has a scientific basis and is used systematically, aiming to optimize individual daily functions and health-related quality of life in patients with morbidity due to chronic diseases measured by clinical or physiological methods.
The effectiveness of pulmonary rehabilitation is well known in the treatment of patients with COPD and in the perioperative lung transplant preparation period. Studies lead to a significant increase in preoperative pulmonary rehabilitation exercise capacity, dyspnea and health-related quality of life.
The aim of our study is to investigate the effects of pulmonary rehabilitation on respiratory tests and quality of life in patients with early and locally advanced NSCLC who received chemotherapy regardless of whether the investigators had undergone surgical treatment.
This study was conducted with outpatients who were diagnosed with small cell lung cancer between 2021-2022, who were approved by the oncologist and physical therapist to participate in a physiotherapy and rehabilitation program. Permission for the study was obtained from the Non-Interventional Local Ethics Committee (decision dated 20.11.2018 and numbered 2018/34). The study was conducted in accordance with the Helsinki Declaration of Patient Rights. Individuals were informed about the study and a written informed consent form was signed by the individuals who volunteered to participate.
Participants Thirty patients aged 18-65 years in remission were included in the study. Surgery, adjuvant chemotherapy and radiotherapy processes of all patients included in the study were completed. Patients with suspected pregnancy, diagnosis of diabetes mellitus, patients in metastatic period, and patients with acute/chronic infection were excluded from the study.
Evaluation The patients' age, gender, height and body weight, medical history and family history information, education status, income level, smoking (pack/year), place of residence, admission to the emergency department in the last year, number of hospital admissions and hospitalizations, and medication used The information was recorded from the patients and their files. Participation of individuals in regular physical activity was questioned. In addition, pre- and post-treatment pain was evaluated using the visual analog scale (VAS).
The evaluations applied to the patients in our study;
- Posture Analysis
- Normal Joint Movement and Evaluation of Muscle Shortness
- Muscle Test
- Six Minute Walking Test
- Physical Activity Level
- Dyspnea Severity
- Quality of Life
- Fatigue Evaluation
Applied Treatments;
- Respiratory Exercises
- Walking Training
- Aerobic exercise training
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group 30 individuals were included in the study. Surgery, adjuvant chemotherapy and radiotherapy processes of all patients included in the study were completed. Patients between the ages of 18-65 and in remission period were included in the study. Patients with suspected pregnancy, diabetes mellitus, metastatic patients, and patients with acute and chronic infections were excluded from the study.
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation | Experimental | Other: Pulmonary RehabilitationPulmonary rehabilitation program will be applied 3 days a week at 40-60% of submaximal heart rate for a total of 8 weeks. Diaphragmatic breathing, pursed lips and segmental breathing exercises will be applied to the patients in the presence of a physiotherapist. Walking and aerobic exercise training will be given. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 18-65, must be in remission.
- Surgery, adjuvant chemotherapy and radiotherapy processes must be completed.
Key exclusion criteria (4 listed)
- Those with suspected pregnancy
- Diabetes mellitus diagnosis
- Patients in the metastatic period
- Patients with a diagnosis of acute/chronic infection were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Rehabilitation1-Pulmonary Rehabilitation: Pulmonary rehabilitation program was applied at 40-60% of submaximal heart rate, 3 days a week for a total of 8 weeks. Diaphragmatic breathing, pursed lip breathing and segmental breathing exercises were practiced with the patients in the company of a physiotherapist. Walking and aerobic exercise training was given. | Other | Pulmonary Rehabilitation |
Primary outcome
Chance from baseline in posture analysis score
Time frame: 8 week
Posture score is going to be assess by posture analysis form to determine change from baseline.
1 secondary outcome
Physical Activity Level
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Lung Cancer and Lung Cancer, Small Cell, run by Hasan Kalyoncu 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deniz Kocamaz, PhD (05375735837, deniz.erdankocamaz@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chance from baseline in posture analysis score (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2022.