Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients|
- Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: No ]To evaluate the magnitude of reduction in irradiated normal tissues (heart and liver) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.
- Toxicity Evaluation [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: No ]To evaluate toxicity of ABC in breast cancer patients receiving adjuvant breast radiotherapy
- Improvement in Normal Tissue Irradiation [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: No ]To evaluate whether potential improvement in normal tissue irradiation can be predicted from standard simulation films, without subjecting patients to free-breathing plus controlled breathingCT scans
- Toxicity Monitoring [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: Yes ]To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||October 2013|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Active Breathing Coordinator
Patients breathe through the ABC device
Device: 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.
Other Name: ABC
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.
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19017|
|Principal Investigator:||Pramila Rani Anne, MD||Thomas Jefferson University|