The Use of Deep Inspiration Breath Hold and Prone Irradiation to Decrease Cardiac Radiation Exposure
- Conditions
- Invasive Breast CancerBreast CancerDuctal Carcinoma in Situ
- Interventions
- Other: Free breathing during radiationOther: Deep Inspiration Breath Hold during Radiation
- Registration Number
- NCT03375892
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- Patients must have a pathologically proven diagnosis of left-sided invasive breast cancer or ductal carcinoma in situ receiving breast/chestwall irradiation +/- regional nodal irradiation, or a right-sided invasive ductal cancer status post-mastectomy or lumpectomy who will be receiving breast/chest wall and nodal irradiation.
- Patients must have undergone breast conserving surgery (i.e. lumpectomy, partial mastectomy) or mastectomy prior to enrollment.
- Patients must be 18 years of age or older.
- Study entry must be prior to CT simulation.
- Per Medical College of Wisconsin Department of Radiation Oncology Standard of Care, women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable forms of contraception during radiation therapy. Patients under age 50 with a uterus and ovaries must have a negative serum pregnancy test within one week of planned CT simulation per Radiation Oncology Departmental guidelines prior to CT simulation.
- Patients must provide study specific informed consent prior to study entry.
- Patients must be able to hold their breath long enough to undergo CT simulation in DIBH (ten to fifteen seconds). The patient should also affirm they can lie in the prone position. This will be determined by the treating radiation oncologist, as per current standard of care.
- Patients who are unable to hold their breath long enough to undergo CT simulation in DIBH. While this may affect patients with chronic obstructive pulmonary disease (COPD) and/or other respiratory conditions, the presence of these comorbidities alone will not exclude patients from enrollment so long as they can maintain breath hold long enough to perform DIBH.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prone Position with no DIBH Free breathing during radiation For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board. Supine Position with no DIBH Free breathing during radiation For the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology. Supine Position with DIBH Deep Inspiration Breath Hold during Radiation For the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology. Prone Position with DIBH Deep Inspiration Breath Hold during Radiation For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board.
- Primary Outcome Measures
Name Time Method Changes in EKG parameters prior to, during or after radiation therapy. 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.
- Secondary Outcome Measures
Name Time Method Change in mitochondrial energy production, as measured in leukocytes (peripheral blood mononuclear cells) from patients prior to and after undergoing radiation therapy. 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).
Changes in left ventricular ejection fraction prior to, during or after radiation therapy. Baseline and 12 months This will be measured as a percentage.
Changes in left atrial volume prior to, during or after radiation therapy. Baseline and 12 months This will be measured in millimeters.
Left ventricular wall thickness prior to, during or after radiation therapy. Baseline and 12 months This will be measured in millimeters.
Arterial and aortic stiffness. 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.
Trial Locations
- Locations (1)
Froedtert Hospital and Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States