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

Study Overview
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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.

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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Active Breathing Coordinator (ABC)
* Radiation: Radiation Therapy


Participation Criteria
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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 Exclusion Criteria: Pregnant women Patients who have had previous ipsilateral breast or thoracic radiation therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Breathing Coordinator<br>Patients breathe through the ABC device | Device: Active Breathing Coordinator (ABC)<br>* 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.<br>* Other names: ABC;Radiation: Radiation Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of Patients With Reduction in Radiation |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity Evaluation | Number of participants that experienced grade three toxicity or higher as a result of treatment. | 30 days post-treatment | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Active Breathing Control, Active Breathing Coordinator, ABC