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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Turkey (Türkiye)1 site
  • Hasan Kalyoncu Univercity

    Gaziantep

Other trials in Turkey (Türkiye)

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;

  1. Posture Analysis
  2. Normal Joint Movement and Evaluation of Muscle Shortness
  3. Muscle Test
  4. Six Minute Walking Test
  5. Physical Activity Level
  6. Dyspnea Severity
  7. Quality of Life
  8. Fatigue Evaluation

Applied Treatments;

  1. Respiratory Exercises
  2. Walking Training
  3. Aerobic exercise training
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 groups in NCT05320458
Study groupRoleWhat they receive
Pulmonary RehabilitationExperimentalPulmonary 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.

  1. 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)
  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.

  1. First posted11 Apr 2022
  2. Study start2 May 2022 (estimated)
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion2 Sep 2022 (estimated)

Resources

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)
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

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.

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