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

Not Applicable

Completed

Interventions: Device: Active Breathing Coordinator (ABC)
Radiation: Radiation Therapy

Brief 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.

Detailed 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 & 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

Arm && Interventions

Group	Intervention	Description
Active Breathing Coordinator	Active Breathing Coordinator (ABC)	Patients breathe through the ABC device
Active Breathing Coordinator	Radiation Therapy	Patients breathe through the ABC device

Primary Outcome Measures

Name	Time	Method
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues	At time of radiation	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.
Proportion of Patients With Reduction in Radiation	30 days

Secondary Outcome Measures

Name	Time	Method
Toxicity Evaluation	30 days post-treatment	Number of participants that experienced grade three toxicity or higher as a result of treatment.
Change in Organs at Risk (OAR) Dosimetric Paramaters	30 days post-treatment	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.
Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.	30 days post-treatment	To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.