The Use of Deep Inspiration Breath Hold and Prone Irradiation to Decrease Cardiac Radiation Exposure

Breast Cancer Clinical Trial

Official title:

A Phase II Study of the Use of Deep Inspiration Breath Hold and Prone Irradiation to Decrease Cardiac Radiation Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375892
• Other study ID #: PRO00030436
• Status: Completed
• Phase: N/A
• Start date: March 3, 2018
• Est. completion date: March 21, 2021

Study information

• Verified date: August 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 21, 2021
• Est. primary completion date: March 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ
• Invasive Breast Cancer
• Respiratory Aspiration

Intervention

Other:
• Deep Inspiration Breath Hold during Radiation
The DIBH technique involves the patient breathing to a specified threshold and then holding that level of inspiration during every radiation therapy field delivered.
• Free breathing during radiation
The patient will be instructed to breathe freely.

Locations

Country	Name	City	State
United States	Froedtert Hospital and Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Changes in left ventricular ejection fraction prior to, during or after radiation therapy.	This will be measured as a percentage.	Baseline and 12 months
Secondary	Changes in left atrial volume prior to, during or after radiation therapy.	This will be measured in millimeters.	Baseline and 12 months
Secondary	Left ventricular wall thickness prior to, during or after radiation therapy.	This will be measured in millimeters.	Baseline and 12 months
Secondary	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