Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
NCT Number: NCT03375892
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Milwaukee, Wisconsin, 53226, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The DIBH technique involves the patient breathing to a specified threshold and then holding that level of inspiration during every radiation therapy field delivered.
The patient will be instructed to breathe freely.
Time frame: Baseline, 6 weeks, 6 months and 12 months
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.
Time frame: baseline, 6 weeks, and 6 and 12 months post-radiation therapy
Mitochondrial energy production will be measured by determining oxygen consumption rate (pmol of O2 consumed per second per·10^6 cells).
Time frame: Baseline and 12 months
This will be measured as a percentage.
Time frame: Baseline and 12 months
This will be measured in millimeters.
Time frame: Baseline and 12 months
This will be measured in millimeters.
Time frame: Baseline and 12 months
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.
Medical College of Wisconsin
Other
A Phase II Study of the Use of Deep Inspiration Breath Hold and Prone Irradiation to Decrease Cardiac Radiation Exposure
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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