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Completed

NCT Number: NCT00328783

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ABC

radiation therapy

Radiation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
May 22, 2006
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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