Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00328783|
Recruitment Status : Completed
First Posted : May 22, 2006
Results First Posted : April 30, 2014
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Active Breathing Coordinator (ABC) Radiation: Radiation Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|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|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
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
- 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 ]Number of participants that experienced grade three toxicity or higher as a result of treatment.
- Change in Organs at Risk (OAR) Dosimetric Paramaters [ Time Frame: 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. [ Time Frame: 30 days post-treatment ]To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328783
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19017|
|Principal Investigator:||Pramila Rani Anne, MD||Thomas Jefferson University|