Small Cell Lung CancerPhase 2NCT01429766
A Prospective Study of Variation in Breath Holding Times at Various Phases of Respiration During the Course of Radiotherapy Including the Effect of Respiratory Training in Lung Cancer Patients
A Phase 2 study testing Respiratory Training in people with Small Cell Lung Cancer and Non Small Cell Lung Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial summary
100 suitable patients of lung cancer shall be taken into the study over a period of 2 years. As per the existing treatment protocol in our department, all patients suitable shall undergo a routine Pulmonary function testing (PFT). Subsequently, recording of the breath hold shall be done at the following times 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Small Cell Lung Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Respiratory Training
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2010to May 2012
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of Small cell and Non small cell lung cancer
- Patients posted for 3DCRT or IMRT or IGRT
Who cannot join
- Patients, who in view of their advanced disease and/or poor general condition would not be able to tolerate radical RT.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Anusheel Munshi, MD, -91-22-24177144, anusheel8@hotmail.com
Jai P Agarwal, MD, -91-22-24177154, jpthm@hotmail.com
About this study
100 suitable patients of lung cancer shall be taken into the study over a period of 2 years. As per the existing treatment protocol in our department, all patients suitable shall undergo a routine Pulmonary function testing (PFT). Subsequently, recording of the breath hold shall be done at the following times
- At time of simulation
- At the time of first fraction of radiotherapy
- At mid radiotherapy
- At radiotherapy conclusion After the recording at a), patients shall be asked to perform deep breathing exercises/spirometer ball exercise to see the effect of training on the breath holding times.
Read the detailed description
100 suitable patients of lung cancer shall be taken into the study over a period of 2 years. As per the existing treatment protocol in our department, all patients suitable shall undergo a routine Pulmonary function testing (PFT). Subsequently, recording of the breath hold shall be done at the following times
- At time of simulation
- At the time of first fraction of radiotherapy
- At mid radiotherapy
- At radiotherapy conclusion After the recording at a), patients shall be asked to perform deep breathing exercises/spirometer ball exercise to see the effect of training on the breath holding times.
Respiratory training All patients shall be sent for respiratory training to the physiotherapy department. Patients shall be counseled about respiratory training by trained staff in their own vernacular. Whenever possible, patients shall be provided one "Spiroball" device and taught how to use the device. In addition/alternatively patients will be taught to do breath exercises. Patients provided with spiroball shall be instructed to use the spiroball by the prescribed technique. The following visit schedule shall be observed
- st visit Within one day of the date of simulation
- nd visit Date of Radiotherapy starting Subsequently 2 visits per week during radiotherapy course shall be conducted (Tuesdays, Thursdays) During all the above visits , respiratory training shall be reinforced and objective recording of the spirometer ball(whenever used) shall be recorded.(Inspiratory volume)
The breathing exercises shall continue through radiotherapy. At all the above times, recording shall be made of the breath holding times. In general at the start of each recording a nasal clip shall be placed and the patient shall be asked to close the mouth voluntarily. The closure of the mouth shall be done after nasal clip placement and then stopwatch for recording shall be started. The end time shall be the moment when the patient opens his mouth and starts breathing again. A one minute pause shall be kept between separate recordings.
- Deep inspiratory breath hold(DIBH): A clip shall be placed on the nose. The patient shall be asked to take a deep breath from his mouth and then hold his breath.
- Deep expiratory breath hold(DEBH): A clip shall be placed on the nose. The patient shall be asked to exhale maximally from the mouth and then hold his breath.
- Normal mid ventilation breath hold(NVBH): A clip shall be placed on the nose. The patient shall be asked to hold breath in the middle of normal respiration.
Beam on/off times As mentioned before, all the patients shall be treated as per existing departmental protocol. However, as a planning component of the study, after the patients have been planned as per the routine protocol, the breath hold data in each phase shall be used to calculate the number of times the radiation beam would have to be needed if patients were treated with the above breath hold timings.
- Conditions
- Small Cell Lung Cancer, Non Small Cell Lung Cancer
- Being tested
- Respiratory Training
- Keywords
- Breath holding times, Phases of respiration, Radiotherapy
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory TrainingOther
All patients shall be sent for respiratory training to the physiotherapy department. Patients shall be counseled about respiratory training by trained staff in their own vernacular. Whenever possible, patients shall be provided one "Spiroball" device and taught how to use the device. In addition/alternatively patients will be taught to do pranayam(breath exercises). Patients provided with spiroball shall be instructed to use the spiroball by the prescribed technique. The following visit schedule shall be observed
- st visit Within one day of the date of simulation
- nd visit Date of Radiotherapy start Subsequently 2 visits per week during radiotherapy course shall be conducted (Tuesdays, Thursdays)
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath holding time in various phases of the respiratory cycle
Breath holding time in deep inspiration, mid ventilation and end expiration
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startJun 2010
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anusheel Munshi, Tata Memorial Hospital
- Investigators
- Anusheel Munshi, MD, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429766
- Sponsor's protocol ID
- 747
- Status last verified
- Sep 2011
- First submitted
- 25 Aug 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Variation in Breath Holding Times at Various Phases of Respiration During the Course of Radiotherapy Including the Effect of Respiratory Training in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT01429766
- Acronym / sponsor ID
- 747
- Conditions
- Small Cell Lung Cancer, Non Small Cell Lung Cancer
- Keywords
- Breath holding times, Phases of respiration, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Jun 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 7 Sep 2011 (estimated)
- 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.
100 suitable patients of lung cancer shall be taken into the study over a period of 2 years. As per the existing treatment protocol in our department, all patients suitable shall undergo a routine Pulmonary function testing (PFT). Subsequently, recording of the breath hold shall be done at the following times
- At time of simulation
- At the time of first fraction of radiotherapy
- At mid radiotherapy
- At radiotherapy conclusion After the recording at a), patients shall be asked to perform deep breathing exercises/spirometer ball exercise to see the effect of training on the breath holding times.
Detailed description
100 suitable patients of lung cancer shall be taken into the study over a period of 2 years. As per the existing treatment protocol in our department, all patients suitable shall undergo a routine Pulmonary function testing (PFT). Subsequently, recording of the breath hold shall be done at the following times
- At time of simulation
- At the time of first fraction of radiotherapy
- At mid radiotherapy
- At radiotherapy conclusion After the recording at a), patients shall be asked to perform deep breathing exercises/spirometer ball exercise to see the effect of training on the breath holding times.
Respiratory training All patients shall be sent for respiratory training to the physiotherapy department. Patients shall be counseled about respiratory training by trained staff in their own vernacular. Whenever possible, patients shall be provided one "Spiroball" device and taught how to use the device. In addition/alternatively patients will be taught to do breath exercises. Patients provided with spiroball shall be instructed to use the spiroball by the prescribed technique. The following visit schedule shall be observed
- st visit Within one day of the date of simulation
- nd visit Date of Radiotherapy starting Subsequently 2 visits per week during radiotherapy course shall be conducted (Tuesdays, Thursdays) During all the above visits , respiratory training shall be reinforced and objective recording of the spirometer ball(whenever used) shall be recorded.(Inspiratory volume)
The breathing exercises shall continue through radiotherapy. At all the above times, recording shall be made of the breath holding times. In general at the start of each recording a nasal clip shall be placed and the patient shall be asked to close the mouth voluntarily. The closure of the mouth shall be done after nasal clip placement and then stopwatch for recording shall be started. The end time shall be the moment when the patient opens his mouth and starts breathing again. A one minute pause shall be kept between separate recordings.
- Deep inspiratory breath hold(DIBH): A clip shall be placed on the nose. The patient shall be asked to take a deep breath from his mouth and then hold his breath.
- Deep expiratory breath hold(DEBH): A clip shall be placed on the nose. The patient shall be asked to exhale maximally from the mouth and then hold his breath.
- Normal mid ventilation breath hold(NVBH): A clip shall be placed on the nose. The patient shall be asked to hold breath in the middle of normal respiration.
Beam on/off times As mentioned before, all the patients shall be treated as per existing departmental protocol. However, as a planning component of the study, after the patients have been planned as per the routine protocol, the breath hold data in each phase shall be used to calculate the number of times the radiation beam would have to be needed if patients were treated with the above breath hold timings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of Small cell and Non small cell lung cancer
- Patients posted for 3DCRT or IMRT or IGRT
Key exclusion criteria (1 listed)
- Patients, who in view of their advanced disease and/or poor general condition would not be able to tolerate radical RT.
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 |
|---|---|---|
| Respiratory TrainingAll patients shall be sent for respiratory training to the physiotherapy department. Patients shall be counseled about respiratory training by trained staff in their own vernacular. Whenever possible, patients shall be provided one "Spiroball" device and taught how to use the device. In addition/alternatively patients will be taught to do pranayam(breath exercises). Patients provided with spiroball shall be instructed to use the spiroball by the prescribed technique. The following visit schedule shall be observed 1. st visit Within one day of the date of simulation 2. nd visit Date of Radiotherapy start Subsequently 2 visits per week during radiotherapy course shall be conducted (Tuesdays, Thursdays) | Other | – |
Primary outcome
Breath holding time in various phases of the respiratory cycle
Time frame: 2 years
Breath holding time in deep inspiration, mid ventilation and end expiration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
- Web site of Tata Memorial HospitalLink provided by the sponsor.
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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.
Anusheel Munshi, MD principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Respiratory Training in people with Small Cell Lung Cancer and Non Small Cell Lung Cancer, run by Tata Memorial Hospital at 1 site in India.
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 1 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 7 Sep 2011. 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 India. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anusheel Munshi, MD (-91-22-24177000 ext. 7144, anusheel8@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath holding time in various phases of the respiratory cycle (time frame: 2 years). 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 7 Sep 2011.