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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: Radiation Therapy; Device: Active Breathing Coordinator (ABC)

Study type: Interventional

Funder types: Other

Identifiers

NCT00328783

02U.282

JT 1005 (Other Identifier)

2002-31 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Active Breathing Coordinator

Experimental group

Description:

Patients breathe through the ABC device

Treatment:

Radiation: Radiation Therapy

Device: Active Breathing Coordinator (ABC)