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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator

Conditions
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Breast Neoplasms, Carcinoma, Ductal, Adenocarcinoma

Intervention / Treatment
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* Device: Active Breathing Coordinator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Left breast/chest wall irradiation with or without ABC (active breathing coordinator)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABC (Active Breathing coordinator)<br>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<br>* A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.<br>|
| No Intervention: No Active Breathing Coordinator<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 6 months post-radiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, SPECT, ABC device, Invasive adenocarcinoma of the left breast, Ductal Carcinoma In Situ of the left breast