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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00328783
First received: May 19, 2006
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Device: Active Breathing Coordinator (ABC)
Radiation: Radiation Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues [ Time Frame: At time of radiation ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity Evaluation [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: No ]
    To evaluate toxicity of ABC in breast cancer patients receiving adjuvant breast radiotherapy

  • Improvement in Normal Tissue Irradiation [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.


Enrollment: 112
Study Start Date: October 2002
Estimated Study Completion Date: October 2015
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: ABC
Radiation: Radiation Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328783

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19017
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Pramila Rani Anne, MD Thomas Jefferson University
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00328783     History of Changes
Other Study ID Numbers: 02U.282, 2002-31
Study First Received: May 19, 2006
Results First Received: January 27, 2014
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Breast cancer
Active Breathing Control
Active Breathing Coordinator
ABC

Additional relevant MeSH terms:
Breast Neoplasms
Respiratory Aspiration
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014