NCT00328783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 30, 2014

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

8.8 years

First QC Date

May 19, 2006

Results QC Date

January 27, 2014

Last Update Submit

April 28, 2025

Conditions

Breast Cancer

Keywords

Breast cancerActive Breathing ControlActive Breathing CoordinatorABC

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Toxicity Evaluation

    30 days post-treatment

  • Change in Organs at Risk (OAR) Dosimetric Paramaters

    30 days post-treatment

  • Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.

    30 days post-treatment

Study Arms (1)

Active Breathing Coordinator

EXPERIMENTAL

Patients breathe through the ABC device

Device: Active Breathing Coordinator (ABC)Radiation: Radiation Therapy

Interventions

Active Breathing Coordinator (ABC)DEVICE

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.

Also known as: ABC
Active Breathing Coordinator
Radiation TherapyRADIATION
Active Breathing Coordinator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women
  • Patients who have had previous ipsilateral breast or thoracic radiation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19017, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Rani Anne, MD
Organization
Thomas Jefferson University
Rani.Anne@jeffersonhospital.org
215-955-6045

Study Officials

  • Pramila Rani Anne, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

October 1, 2002

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 30, 2025

Results First Posted

April 30, 2014

Record last verified: 2025-04

Locations

US(1)