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Clinical Trials/NCT01429766
NCT01429766UnknownPhase 2

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

Tata Memorial Hospital2 sites in 1 country100 target enrollmentStarted: June 1, 2010Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Enrollment
100
Locations
2
Primary Endpoint
Breath holding time in various phases of the respiratory cycle

Study Overview

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

  1. At time of simulation
  2. At the time of first fraction of radiotherapy
  3. At mid radiotherapy
  4. 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

  1. At time of simulation
  2. At the time of first fraction of radiotherapy
  3. At mid radiotherapy
  4. 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

  1. st visit Within one day of the date of simulation
  2. 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Anusheel Munshi

Associate Professor

Tata Memorial Hospital

Study Sites (2)

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