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

This study is currently recruiting participants.

Verified by Thomas Jefferson University, April 2007

First Received: May 19, 2006 Last Updated: April 23, 2007 History of Changes

Sponsored by:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00328783

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)

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study Investigation of the Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

Dosimetric evaluation of the magnitude of the reduction in radiation dose to the liver and heart when comparing ABC to standard (free breathing)

Secondary Outcome Measures:

Adverse events and procedural and technical success rate

Estimated Enrollment:	103
Study Start Date:	October 2002
Estimated Study Completion Date:	October 2009

Detailed Description:

To evaluate the magnitude of reduction in irradiated normal tissues (heart and liver) when using ABC in breast patients
To evaluate toxicity of ABC in breast cancer patients receiving adjuvant breast radiotherapy
To evaluate whether potential improvement in normal tissue irradiation can be predicted from standard simulation films, without subjecting patients to free-breathing plus controlled breathing CT scans
To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device

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

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

Contacts

Contact: Pramila Rani Anne', MD	215-955-6045	rani.anne@mail.tju.edu
Contact: Gayle Mallon, CCRP	215-955-8619	gayle.mallon@mail.tju.edu

Locations

United States, Pennsylvania
Thomas Jefferson University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19017
Contact: Pramila Rani Anne', MD 215-955-6045 rani.anne@mail.tju.edu
Contact: Maria Werner-Wasik, MD 215-955-6705 maria.werner-wasik@mail.tju.edu
Principal Investigator: Pramila Rani Anne', MD

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

Pramila Rani Anne', MD

Thomas Jefferson University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	02U.282
Study First Received:	May 19, 2006
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00328783 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:

Breast cancer
Patients receiving radiation therapy for breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009