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
Primary Purpose
Small Cell Lung Cancer, Non Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Respiratory Training
Sponsored by
About this trial
This is an interventional supportive care trial for Small Cell Lung Cancer focused on measuring Breath holding times, Phases of respiration, Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Patients of Small cell and Non small cell lung cancer
- Patients posted for 3DCRT or IMRT or IGRT
Exclusion Criteria:
- Patients, who in view of their advanced disease and/or poor general condition would not be able to tolerate radical RT.
Sites / Locations
- Tata Memorial HospitalRecruiting
Outcomes
Primary Outcome Measures
Breath holding time in various phases of the respiratory cycle
Breath holding time in deep inspiration, mid ventilation and end expiration
Secondary Outcome Measures
Full Information
NCT ID
NCT01429766
First Posted
August 25, 2011
Last Updated
September 6, 2011
Sponsor
Tata Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01429766
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer, Non Small Cell Lung Cancer
Keywords
Breath holding times, Phases of respiration, Radiotherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Respiratory Training
Intervention Description
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)
Primary Outcome Measure Information:
Title
Breath holding time in various phases of the respiratory cycle
Description
Breath holding time in deep inspiration, mid ventilation and end expiration
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of Small cell and Non small cell lung cancer
Patients posted for 3DCRT or IMRT or IGRT
Exclusion Criteria:
Patients, who in view of their advanced disease and/or poor general condition would not be able to tolerate radical RT.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anusheel Munshi, MD
Phone
-91-22-24177000
Ext
7144
Email
anusheel8@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anusheel Munshi, MD
Organizational Affiliation
Tata Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anusheel Munshi, MD
Phone
-91-22-24177144
Email
anusheel8@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jai P Agarwal, MD
Phone
-91-22-24177154
Email
jpthm@hotmail.com
12. IPD Sharing Statement
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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
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