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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00002394 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC (Active Breathing coordinator) | Experimental | 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. |
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| No Active Breathing Coordinator | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Breathing Coordinator | Device | A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score | 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. | Baseline (pre-radiation) to 6 months (post-radiation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Zellars, M.D. | Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24606847 | Result | Zellars R, Bravo PE, Tryggestad E, Hopfer K, Myers L, Tahari A, Asrari F, Ziessman H, Garrett-Mayer E. SPECT analysis of cardiac perfusion changes after whole-breast/chest wall radiation therapy with or without active breathing coordinator: results of a randomized phase 3 trial. Int J Radiat Oncol Biol Phys. 2014 Mar 15;88(4):778-85. doi: 10.1016/j.ijrobp.2013.12.035. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Breathing Coordination | 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. Patients in this group were treated with Active Breathing Coordinator: A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion |
| FG001 | No Active Breathing Coordination | 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. (Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Baseline characteristics were only collected for participants who completed study interventions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Breathing Coordination | 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. Patients in this group were treated with Active Breathing Coordinator: A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score | 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. | We understand the reporting score on a scale however, in this case the Mean Perfusion Score was utilized. | Posted | Mean | Standard Deviation | Mean Perfusion Score | Baseline (pre-radiation) to 6 months (post-radiation) |
|
Baseline (pretreatment) to 48 months posttreatment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Breathing Coordination | 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. Patients in this group were treated with Active Breathing Coordinator: A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Zellars | Indiana University | 3179444505 | rzellars@iu.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Left breast/chest wall irradiation with or without ABC (active breathing coordinator)
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| BG001 | No Active Breathing Coordination | 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. (Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | No Active Breathing Coordination | 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. (Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion |
|
|
| 2 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | No Active Breathing Coordination | 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. (Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion | 1 | 21 | 0 | 21 | 0 | 21 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |