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This study aims to discover more about radiation techniques for people treated for left-sided breast cancer that minimizes exposure to the heart, as noted by mean heart dose.
This study aims to discover more about radiation techniques for people treated for left-sided breast cancer that minimizes exposure to the heart, as noted by mean heart dose. Both prone (lying face down) radiation and Deep Inspiration Breath Hold (DIBH) are more labor-intensive and usually require longer treatment times for patients than traditional supine (lying face up) free-breathing radiation treatments. Thus, identifying people that benefit most from these techniques can better utilize resources. This study compares supine and prone positioning, with or without DIBH, to further assess which positioning technique will achieve the lowest cardiac radiation doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prone Position with DIBH | Active Comparator | For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board. |
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| Supine Position with DIBH | Active Comparator | For the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology. |
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| Prone Position with no DIBH | Active Comparator | For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board. |
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| Supine Position with no DIBH | Active Comparator | For the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Inspiration Breath Hold during Radiation | Other | The DIBH technique involves the patient breathing to a specified threshold and then holding that level of inspiration during every radiation therapy field delivered. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in EKG parameters prior to, during or after radiation therapy. | Changes in QRS wave form will be categorized as 'present' or 'absent' based on the presentation (or lack) of a r' wave, or notched r or s wave on the EKG tracing. QRS-T angle will be measured in degrees. | Baseline, 6 weeks, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mitochondrial energy production, as measured in leukocytes (peripheral blood mononuclear cells) from patients prior to and after undergoing radiation therapy. | Mitochondrial energy production will be measured by determining oxygen consumption rate (pmol of O2 consumed per second per·10^6 cells). | baseline, 6 weeks, and 6 and 12 months post-radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Currey, MD, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| Free breathing during radiation | Other | The patient will be instructed to breathe freely. |
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| Changes in left ventricular ejection fraction prior to, during or after radiation therapy. | This will be measured as a percentage. | Baseline and 12 months |
| Changes in left atrial volume prior to, during or after radiation therapy. | This will be measured in millimeters. | Baseline and 12 months |
| Left ventricular wall thickness prior to, during or after radiation therapy. | This will be measured in millimeters. | Baseline and 12 months |
| Arterial and aortic stiffness. | This will be assessed by measuring the ascending aortic diameters 3 cm above the aortic valve at end-diastole and end-systole in the 2D parasternal view. | Baseline and 12 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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