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

NCT01429766 | Unknown Phase 2 DMC

• 1 other identifier: 747
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Small Cell Lung Cancer; Non Small Cell Lung Cancer

Keywords

Breath holding times; Phases of respiration; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Breath holding time in various phases of the respiratory cycle

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

  2 years

Interventions

Respiratory Training OTHER

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 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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Links

• Web site of Tata Memorial Hospital

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Anusheel Munshi, MD

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anusheel Munshi, MD

CONTACT

-91-22-24177000; anusheel8@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: September 7, 2011
• Study Start: June 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

IN (1)