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Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00321048
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief Summary:
Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases radiation exposure to the heart during radiation for breast cancer. In this trial cardiac perfusion changes or lack thereof will be quantified in women treated with radiation for breast cancer while using the ABC device. The control group of the study will consist of patients randomized to radiation therapy without the ABC device.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Carcinoma, Ductal Adenocarcinoma Device: Active Breathing Coordinator Not Applicable

Detailed Description:

50 left sided breast cancer patients will be randomized to receive breast/chest wall irradiation with or without ABC. Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.

After the completion of radiation therapy, patients will be seen on the following schedule:

A follow up examination will take place every 3-6 months for the first two years, then every 4-6 months for years for the next 3 years. After 5 years follow-up evaluations will occur annually. A SPECT scan will be obtained at 6 months post therapy.

Patients must be 18 and older and must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.

Patients must have also undergone a segmental mastectomy (SM) or Mastectomy.

Patients must not have received prior radiation therapy to the breast at any time for any reason.

Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Left breast/chest wall irradiation with or without ABC (active breathing coordinator)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator
Study Start Date : June 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ABC (Active Breathing coordinator)
Patients are randomized to ABC arm will receive radiation with ABC. Cardiac perfusion will be assessed at baseline and 6 months after treatment and the difference will be compared to that seen in the No ABC arm.
 Device: Active Breathing Coordinator
A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.
No Intervention: No Active Breathing Coordinator
Patients randomized to the No ABC arm will receive radiation without ABC.Cardiac perfusion will be assessed at baseline and 6 months after treatment and the difference will be compared to that seen in the ABC arm.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score [ Time Frame: 6 months post-radiation ]
    Efficacy of the ABC device in protecting the heart from radiation (XRT) damage in patients with L breast cancer is determined by the change in cardiac perfusion (mean apical perfusion score) as measured by SPECT between baseline and 6 month follow up. A score of 1 represents an equivocal or mild reduction in perfusion, 2 represents moderately reduced perfusion, 3 represents severely reduced perfusion, and 4 indicates absent perfusion.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient must be 18 and older
  • Patients must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.
  • Patients must have undergone a segmental mastectomy (SM) or Mastectomy
  • Patients must not have received prior radiation therapy to the breast at any time for any reason.
  • Any patient with active local-regional disease prior to registration is not eligible.
  • Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy.
  • Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.
  • All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

  • Patients requiring oxygen
  • Sarcoma or Squamous Cell pathology
  • Right-sided breast cancers
  • Metastatic disease to the breast
Contacts and Locations
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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): NCT00321048


Locations
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United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breast Cancer Research Foundation
Investigators
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Principal Investigator: Richard Zellars, M.D. Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology
More Information
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Publications of Results:

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00321048    
Other Study ID Numbers: J0609
NA_00002394 ( Other Identifier: JHM IRB )
First Posted: May 3, 2006    Key Record Dates
Results First Posted: June 19, 2019
Last Update Posted: June 19, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
breast cancer
SPECT
ABC device
Invasive adenocarcinoma of the left breast
Ductal Carcinoma In Situ of the left breast
Additional relevant MeSH terms:
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Adenocarcinoma
Breast Neoplasms
Carcinoma, Ductal
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Ductal, Lobular, and Medullary