Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328783
• Other study ID #: 02U.282
• Secondary ID: 2002-31
• Status: Completed
• Phase: N/A
• First received: May 19, 2006
• Last updated: December 11, 2017
• Start date: October 2002
• Est. completion date: July 2011

Study information

• Verified date: December 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.

Description:

The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields

• Adequate pulmonary function

• Presence of 5 cc of the heart or liver with the simulation fields

• Karnofsky Performance Status (KPS) equal to or greater than 70

Exclusion Criteria:

• Pregnant women

• Patients who have had previous ipsilateral breast or thoracic radiation therapy

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Respiratory Aspiration

Intervention

Device:
• Active Breathing Coordinator (ABC)
The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.

Radiation:
• Radiation Therapy

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues	To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.; The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose.	At time of radiation
Primary	Proportion of Patients With Reduction in Radiation		30 days
Secondary	Toxicity Evaluation	Number of participants that experienced grade three toxicity or higher as a result of treatment.	30 days post-treatment
Secondary	Change in Organs at Risk (OAR) Dosimetric Paramaters	To evaluate the magnitude of change in Mean Heart Dose (MHD) and Left lung dose when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.	30 days post-treatment
Secondary	Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.	To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.	30 days post-treatment

External Links

•   Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
•   Thomas Jefferson University Hospitals