Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer

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

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Radiation Therapy; Device: Active Breathing Coordinator (ABC)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19017
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Breathing Coordinator; Patients breathe through the ABC device	Radiation: Radiation Therapy; 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 Names: ABC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues	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.	At time of radiation
Proportion of Patients With Reduction in Radiation		30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity Evaluation	Number of participants that experienced grade three toxicity or higher as a result of treatment.	30 days post-treatment
Change in Organs at Risk (OAR) Dosimetric Paramaters	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.	30 days post-treatment
Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.	To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.	30 days post-treatment

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Pramila Rani Anne, MD, Thomas Jefferson University

Publications and helpful links

Helpful Links

• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Thomas Jefferson University Hospitals

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: May 19, 2006
• First Submitted That Met QC Criteria: May 19, 2006
• First Posted (Estimated): May 22, 2006

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; ABC; Active Breathing Control; Active Breathing Coordinator
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiration Disorders; Skin Diseases; Breast Diseases; Breast Neoplasms; Respiratory Aspiration
• Other Study ID Numbers: 02U.282; 2002-31 (Other Identifier: CCRRC); JT 1005 (Other Identifier: JeffTrial Number)