Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer
|Breast Cancer||Device: Active Breathing Coordinator (ABC) Radiation: Radiation Therapy|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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: 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 [ Time Frame: 30 days ]
- Toxicity Evaluation [ Time Frame: 30 days post-treatment ]To evaluate toxicity of ABC in breast cancer patients receiving adjuvant breast radiotherapy
- Improvement in Normal Tissue Irradiation [ Time Frame: 30 days post-treatment ]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 ]To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.
|Study Start Date:||October 2002|
|Study Completion Date:||July 2011|
|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: ABCRadiation: Radiation Therapy
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328783
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19017|
|Principal Investigator:||Pramila Rani Anne, MD||Thomas Jefferson University|