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

September 6, 2011 updated by: Anusheel Munshi, Tata Memorial Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

  1. 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.
  2. 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.
  3. 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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients of Small cell and Non small cell lung cancer
  2. Patients posted for 3DCRT or IMRT or IGRT

Exclusion Criteria:

  1. Patients, who in view of their advanced disease and/or poor general condition would not be able to tolerate radical RT.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Investigators

  • Principal Investigator: Anusheel Munshi, MD, Tata Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 6, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 747

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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