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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Breathing Coordinator (ABC)
Radiation Therapy
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Active Breathing Control, Active Breathing Coordinator, ABC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Breathing Coordinator

Arm Description

Patients breathe through the ABC device

Outcomes

Primary Outcome Measures

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.
Proportion of Patients With Reduction in Radiation

Secondary Outcome Measures

Toxicity Evaluation
Number of participants that experienced grade three toxicity or higher as a result of 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.
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.

Full Information

First Posted
May 19, 2006
Last Updated
December 11, 2017
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT00328783
Brief Title
Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer
Official Title
A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Active Breathing Control, Active Breathing Coordinator, ABC

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Breathing Coordinator
Arm Type
Experimental
Arm Description
Patients breathe through the ABC device
Intervention Type
Device
Intervention Name(s)
Active Breathing Coordinator (ABC)
Other Intervention Name(s)
ABC
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Primary Outcome Measure Information:
Title
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues
Description
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.
Time Frame
At time of radiation
Title
Proportion of Patients With Reduction in Radiation
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Toxicity Evaluation
Description
Number of participants that experienced grade three toxicity or higher as a result of treatment.
Time Frame
30 days post-treatment
Title
Change in Organs at Risk (OAR) Dosimetric Paramaters
Description
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.
Time Frame
30 days post-treatment
Title
Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.
Description
To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.
Time Frame
30 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pramila Rani Anne, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19017
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.JeffersonHospital.org
Description
Thomas Jefferson University Hospitals

Learn more about this trial

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

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