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A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues

Outcome Description:

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.

Outcome Time Frame:

30 days post-treatment

Safety Issue:

No

Principal Investigator

Pramila Rani Anne, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University

Authority:

United States: Institutional Review Board

Study ID:

02U.282

NCT ID:

NCT00328783

Start Date:

October 2002

Completion Date:

October 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Active Breathing Control
  • Active Breathing Coordinator
  • ABC
  • Respiratory Aspiration
  • Breast Neoplasms

Name

Location
Thomas Jefferson University Hospital Philadelphia, Pennsylvania  19131