This trial is active, not recruiting.

Condition breast cancer
Treatments active breathing coordinator (abc), radiation therapy
Sponsor Thomas Jefferson University
Start date October 2002
End date July 2011
Trial size 112 participants
Trial identifier NCT00328783, 02U.282, 2002-31


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Patients breathe through the ABC device
active breathing coordinator (abc) 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.
radiation therapy

Primary Outcomes

Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues
time frame: At time of radiation
Proportion of Patients With Reduction in Radiation
time frame: 30 days

Secondary Outcomes

Toxicity Evaluation
time frame: 30 days post-treatment
Improvement in Normal Tissue Irradiation
time frame: 30 days post-treatment
Toxicity Monitoring
time frame: 30 days post-treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients
Principal investigator Pramila Rani Anne, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Thomas Jefferson University.