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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


Phase 2
N/A
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer, Non Small Cell Lung Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Breath holding time in various phases of the respiratory cycle

Outcome Description:

Breath holding time in deep inspiration, mid ventilation and end expiration

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Anusheel Munshi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tata Memorial Hospital

Authority:

India: Indian Council of Medical Research

Study ID:

747

NCT ID:

NCT01429766

Start Date:

June 2010

Completion Date:

May 2012

Related Keywords:

  • Small Cell Lung Cancer
  • Non Small Cell Lung Cancer
  • Breath holding times
  • Phases of respiration
  • Radiotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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