CancerNCT07532057
Pulmonary Rehabilitation During Chemotherapy in Stage IIIB/IV Small Cell Lung Cancer
A study testing Supervised Pulmonary Rehabilitation Plus Home Program and Home Breathing, Coughing, and Walking Program in people with Cancer and Lung Neoplasms, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This single-center, parallel-group randomized trial evaluated whether adding an 8-week physiotherapist-supervised pulmonary rehabilitation program to a home program improved functional exercise capacity, pulmonary function, and lung cancer symptoms in adults with stage IIIB/IV small cell lung cancer receiving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung Neoplasms, Lung Cancer Small Cell Lung Cancer (SCLC)
- What is being tested?
- Supervised Pulmonary Rehabilitation Plus Home Program and Home Breathing, Coughing, and Walking Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 30 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed small cell lung cancer, Stage IIIB or Stage IV
- Age 18 years or older
- Receiving active chemotherapy with no more than 3 completed chemotherapy cycles at enrollment
- Eastern Cooperative Oncology Group Performance Status 0, 1, or 2
- Able to understand the intervention instructions
- Written informed consent provided
Who cannot join
- Stage I or Stage II small cell lung cancer
- Any complication contraindicating pulmonary rehabilitation, including a pathological fracture, open wound, unstable cardiac disease, or active uncontrolled infection
- Inability or refusal to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeditepe University Hospital, Oncology Department
Istanbul
About this study
Official title: Pulmonary Rehabilitation During Chemotherapy in Stage IIIB/IV Small Cell Lung Cancer: A Randomized Controlled Trial
This single-center, parallel-group randomized trial evaluated whether adding an 8-week physiotherapist-supervised pulmonary rehabilitation program to a home program improved functional exercise capacity, pulmonary function, and lung cancer symptoms in adults with stage IIIB/IV small cell lung cancer receiving chemotherapy. Thirty participants were randomized 1:1 to 9 scheduled face-to-face rehabilitation contacts plus twice-daily home exercise and comfortable-pace walking for 20 minutes per day, or to a home program of breathing exercises, coughing or huffing, and comfortable-pace walking for 20 minutes per day without face-to-face rehabilitation. Outcomes were assessed at baseline and after 8 weeks. The principal functional outcome for this report was change in 6-minute walk distance; spirometry and the 9-domain Lung Cancer Symptom Scale were exploratory outcomes.
Read the detailed description
BACKGROUND: Patients with stage IIIB/IV small cell lung cancer receiving chemotherapy can experience deterioration in pulmonary function, exercise capacity, symptoms, and quality of life. Evidence for pulmonary rehabilitation during active chemotherapy remains limited.
STUDY DESIGN: Single-center, parallel-group, open-label randomized controlled trial conducted from November 2018 through May 2019.
SETTING: Oncology Department, Yeditepe University Hospital, Istanbul, Turkey.
ETHICS AND REGISTRATION: The Haliç University Ethics Committee approved the study (No. 109; October 30, 2018), and all participants provided written informed consent before enrollment. The trial was retrospectively registered on April 15, 2026.
PARTICIPANTS: Adults aged 18 years or older with stage IIIB/IV small cell lung cancer, Eastern Cooperative Oncology Group performance status 0-2, active chemotherapy, and no more than 3 completed chemotherapy cycles at enrollment. Participants had to understand the intervention instructions and provide written informed consent. Patients with stage I/II disease or a complication contraindicating pulmonary rehabilitation were excluded.
INTERVENTION GROUP: Nine scheduled face-to-face, physiotherapist-supervised contacts across 8 weeks were used to teach and monitor diaphragmatic and thoracic expansion exercises; postural drainage with percussion when indicated; active-cycle breathing, huffing, and effective coughing; upper- and lower-limb resistance exercises; and walking. The home program was prescribed twice daily, with comfortable-pace walking for 20 minutes per day.
CONTROL GROUP: An 8-week home program of diaphragmatic and thoracic breathing exercises, coughing or huffing, and comfortable-pace walking for 20 minutes per day. The control program did not include face-to-face pulmonary rehabilitation, resistance training, postural drainage or percussion, or active-cycle breathing.
OUTCOMES: Change in 6-minute walk distance from baseline to 8 weeks was designated the principal functional outcome for this report. Exploratory outcomes were forced vital capacity, forced expiratory volume in 1 second, FEV1/FVC, peak expiratory flow, forced expiratory flow at 25%-75% of forced vital capacity, and the 9-domain Lung Cancer Symptom Scale, assessed at baseline and after 8 weeks. No prospectively documented primary-secondary outcome hierarchy was located in the available source records.
- Being tested
- Supervised Pulmonary Rehabilitation Plus Home Program, Home Breathing, Coughing, and Walking Program
- Medical subject headings
- Neoplasms, 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.
Supervised Pulmonary Rehabilitation Plus Home ProgramBehavioural
Eight-week program with 9 scheduled face-to-face, physiotherapist-supervised contacts. The contacts were used to teach and monitor diaphragmatic and thoracic expansion exercises; postural drainage with percussion when indicated; active-cycle breathing, huffing, and effective coughing; upper- and lower-limb resistance exercises; and walking. The prescribed home program was performed twice daily, with comfortable-pace walking for 20 minutes per day.
Home Breathing, Coughing, and Walking ProgramBehavioural
Eight-week home program consisting of diaphragmatic and thoracic breathing exercises, effective coughing or huffing, and comfortable-pace walking for 20 minutes per day. No face-to-face pulmonary rehabilitation, resistance training, postural drainage/percussion, or active-cycle breathing was provided.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Pulmonary Rehabilitation Plus Home Program | Experimental | Eight-week program with 9 scheduled face-to-face, physiotherapist-supervised contacts. The contacts were used to teach and monitor diaphragmatic and thoracic expansion exercises; postural drainage with percussion when indicated; active-cycle breathing, huffing, and effective coughing; upper- and lower-limb resistance exercises; and walking. The prescribed home program was performed twice daily, with comfortable-pace walking for 20 minutes per day. Receives: Behavioral: Supervised Pulmonary Rehabilitation Plus Home Program |
| Home Breathing, Coughing, and Walking Program | Active comparator | Eight-week home program consisting of diaphragmatic and thoracic breathing exercises, effective coughing or huffing, and comfortable-pace walking for 20 minutes per day. No face-to-face pulmonary rehabilitation, resistance training, postural drainage/percussion, or active-cycle breathing was provided. Receives: Behavioral: Home Breathing, Coughing, and Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-Minute Walk Test Distance
Functional exercise capacity measured as the distance walked in a 30-meter indoor corridor. Change is calculated as the Week 8 value minus the baseline value and is reported in meters.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Nov 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Halic University
- Responsible party
- Principal investigator, dogukan kurc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532057
- Sponsor's protocol ID
- HALIC-EC-109-2018
- Status last verified
- Aug 2026
- First submitted
- 8 Apr 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A de-identified analytic dataset, data dictionary, and reproducible statistical code may be made available by the corresponding author on reasonable request, subject to ethics, institutional, and consent constraints.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation During Chemotherapy in Stage IIIB/IV Small Cell Lung Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07532057
- Acronym / sponsor ID
- HALIC-EC-109-2018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Halic University
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 15 Apr 2026 (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.
This single-center, parallel-group randomized trial evaluated whether adding an 8-week physiotherapist-supervised pulmonary rehabilitation program to a home program improved functional exercise capacity, pulmonary function, and lung cancer symptoms in adults with stage IIIB/IV small cell lung cancer receiving chemotherapy. Thirty participants were randomized 1:1 to 9 scheduled face-to-face rehabilitation contacts plus twice-daily home exercise and comfortable-pace walking for 20 minutes per day, or to a home program of breathing exercises, coughing or huffing, and comfortable-pace walking for 20 minutes per day without face-to-face rehabilitation. Outcomes were assessed at baseline and after 8 weeks. The principal functional outcome for this report was change in 6-minute walk distance; spirometry and the 9-domain Lung Cancer Symptom Scale were exploratory outcomes.
Detailed description
BACKGROUND: Patients with stage IIIB/IV small cell lung cancer receiving chemotherapy can experience deterioration in pulmonary function, exercise capacity, symptoms, and quality of life. Evidence for pulmonary rehabilitation during active chemotherapy remains limited.
STUDY DESIGN: Single-center, parallel-group, open-label randomized controlled trial conducted from November 2018 through May 2019.
SETTING: Oncology Department, Yeditepe University Hospital, Istanbul, Turkey.
ETHICS AND REGISTRATION: The Haliç University Ethics Committee approved the study (No. 109; October 30, 2018), and all participants provided written informed consent before enrollment. The trial was retrospectively registered on April 15, 2026.
PARTICIPANTS: Adults aged 18 years or older with stage IIIB/IV small cell lung cancer, Eastern Cooperative Oncology Group performance status 0-2, active chemotherapy, and no more than 3 completed chemotherapy cycles at enrollment. Participants had to understand the intervention instructions and provide written informed consent. Patients with stage I/II disease or a complication contraindicating pulmonary rehabilitation were excluded.
INTERVENTION GROUP: Nine scheduled face-to-face, physiotherapist-supervised contacts across 8 weeks were used to teach and monitor diaphragmatic and thoracic expansion exercises; postural drainage with percussion when indicated; active-cycle breathing, huffing, and effective coughing; upper- and lower-limb resistance exercises; and walking. The home program was prescribed twice daily, with comfortable-pace walking for 20 minutes per day.
CONTROL GROUP: An 8-week home program of diaphragmatic and thoracic breathing exercises, coughing or huffing, and comfortable-pace walking for 20 minutes per day. The control program did not include face-to-face pulmonary rehabilitation, resistance training, postural drainage or percussion, or active-cycle breathing.
OUTCOMES: Change in 6-minute walk distance from baseline to 8 weeks was designated the principal functional outcome for this report. Exploratory outcomes were forced vital capacity, forced expiratory volume in 1 second, FEV1/FVC, peak expiratory flow, forced expiratory flow at 25%-75% of forced vital capacity, and the 9-domain Lung Cancer Symptom Scale, assessed at baseline and after 8 weeks. No prospectively documented primary-secondary outcome hierarchy was located in the available source records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Pulmonary Rehabilitation Plus Home Program | Experimental | Behavioral: Supervised Pulmonary Rehabilitation Plus Home ProgramEight-week program with 9 scheduled face-to-face, physiotherapist-supervised contacts. The contacts were used to teach and monitor diaphragmatic and thoracic expansion exercises; postural drainage with percussion when indicated; active-cycle breathing, huffing, and effective coughing; upper- and lower-limb resistance exercises; and walking. The prescribed home program was performed twice daily, with comfortable-pace walking for 20 minutes per day. |
| Home Breathing, Coughing, and Walking Program | Active comparator | Behavioral: Home Breathing, Coughing, and Walking ProgramEight-week home program consisting of diaphragmatic and thoracic breathing exercises, effective coughing or huffing, and comfortable-pace walking for 20 minutes per day. No face-to-face pulmonary rehabilitation, resistance training, postural drainage/percussion, or active-cycle breathing was provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed small cell lung cancer, Stage IIIB or Stage IV
- Age 18 years or older
- Receiving active chemotherapy with no more than 3 completed chemotherapy cycles at enrollment
- Eastern Cooperative Oncology Group Performance Status 0, 1, or 2
- Able to understand the intervention instructions
Key exclusion criteria (3 listed)
- Stage I or Stage II small cell lung cancer
- Any complication contraindicating pulmonary rehabilitation, including a pathological fracture, open wound, unstable cardiac disease, or active uncontrolled infection
- Inability or refusal to provide written informed consent
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 |
|---|---|---|
| Supervised Pulmonary Rehabilitation Plus Home ProgramEight-week program with 9 scheduled face-to-face, physiotherapist-supervised contacts. The contacts were used to teach and monitor diaphragmatic and thoracic expansion exercises; postural drainage with percussion when indicated; active-cycle breathing, huffing, and effective coughing; upper- and lower-limb resistance exercises; and walking. The prescribed home program was performed twice daily, with comfortable-pace walking for 20 minutes per day. | Behavioural | Supervised Pulmonary Rehabilitation Plus Home Program |
| Home Breathing, Coughing, and Walking ProgramEight-week home program consisting of diaphragmatic and thoracic breathing exercises, effective coughing or huffing, and comfortable-pace walking for 20 minutes per day. No face-to-face pulmonary rehabilitation, resistance training, postural drainage/percussion, or active-cycle breathing was provided. | Behavioural | Home Breathing, Coughing, and Walking Program |
Primary outcome
Change in 6-Minute Walk Test Distance
Time frame: Baseline and Week 8
Functional exercise capacity measured as the distance walked in a 30-meter indoor corridor. Change is calculated as the Week 8 value minus the baseline value and is reported in meters.
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 5 Nov 2026.
- Individual participant dataSharing planned: Undecided. A de-identified analytic dataset, data dictionary, and reproducible statistical code may be made available by the corresponding author on reasonable request, subject to ethics, institutional, and consent constraints.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Pulmonary Rehabilitation Plus Home Program and Home Breathing, Coughing, and Walking Program in people with Cancer and Lung Neoplasms, run by Istanbul Medipol University Hospital 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 6 inclusion and 3 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 5 Nov 2026. 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?
Change in 6-Minute Walk Test Distance (time frame: Baseline and Week 8). 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 5 Nov 2026.