Clinical trial NCT03375892: The Use of Deep Inspiration Breath Hold and Prone Irradiation to Decrease Cardiac Radiation Exposure
Official title: A Phase II Study of the Use of Deep Inspiration Breath Hold and Prone Irradiation to Decrease Cardiac Radiation Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Ductal Carcinoma in Situ
Invasive Breast Cancer
Keywords: radiation
Deep Inspiration Breath Hold
stage I
stage II
stage IIa
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in EKG parameters prior to, during or after radiation therapy.
timeFrame: Baseline, 6 weeks, 6 months and 12 months
Secondary outcomes:
measure: Change in mitochondrial energy production, as measured in leukocytes (peripheral blood mononuclear cells) from patients prior to and after undergoing radiation therapy.
timeFrame: baseline, 6 weeks, and 6 and 12 months post-radiation therapy
measure: Changes in left ventricular ejection fraction prior to, during or after radiation therapy.
timeFrame: Baseline and 12 months
measure: Changes in left atrial volume prior to, during or after radiation therapy.
timeFrame: Baseline and 12 months
measure: Left ventricular wall thickness prior to, during or after radiation therapy.
timeFrame: Baseline and 12 months
measure: Arterial and aortic stiffness.
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Adam Currey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: