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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
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Device: Active Breathing Coordinator (ABC) Radiation: Radiation Therapy Not Applicable

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  (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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


  2. Proportion of Patients With Reduction in Radiation [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Toxicity Evaluation [ Time Frame: 30 days post-treatment ]
    Number of participants that experienced grade three toxicity or higher as a result of treatment.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19017
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
Principal Investigator: Pramila Rani Anne, MD Thomas Jefferson University

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00328783     History of Changes
Other Study ID Numbers: 02U.282
2002-31 ( Other Identifier: CCRRC )
First Posted: May 22, 2006    Key Record Dates
Results First Posted: April 30, 2014
Last Update Posted: January 11, 2018
Last Verified: December 2017

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at 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