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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Active Breathing Coordinator

Patients breathe through the ABC device

Group Type EXPERIMENTAL

Active Breathing Coordinator (ABC)

Intervention Type DEVICE

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 Therapy

Intervention Type RADIATION

Interventions

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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.

Intervention Type DEVICE

Radiation Therapy

Intervention Type RADIATION

Other Intervention Names

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ABC

Eligibility Criteria

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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