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

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University112 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

112

Conditions

Breast Cancer

Interventions

Active Breathing Coordinator (ABC)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 TherapyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: At time of radiation

Proportion of Patients With Reduction in Radiation

Time frame: 30 days

Secondary Outcomes

Toxicity Evaluation

Number of participants that experienced grade three toxicity or higher as a result of treatment.

Time frame: 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.

Time frame: 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.

Time frame: 30 days post-treatment

Data from ClinicalTrials.gov

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