Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC
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|ClinicalTrials.gov Identifier: NCT00321048|
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : June 19, 2019
Last Update Posted : June 19, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Carcinoma, Ductal Adenocarcinoma||Device: Active Breathing Coordinator||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Left breast/chest wall irradiation with or without ABC (active breathing coordinator)|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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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|
- 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.
- Patients requiring oxygen
- Sarcoma or Squamous Cell pathology
- Right-sided breast cancers
- Metastatic disease to the breast
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
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Richard Zellars, M.D.||Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology|
|Responsible Party:||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Other Study ID Numbers:||
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|
Invasive adenocarcinoma of the left breast
Ductal Carcinoma In Situ of the left breast
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary