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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Invasive Breast Cancer; Ductal Carcinoma in Situ
• Intervention / Treatment: Other: Deep Inspiration Breath Hold during Radiation; Other: Free breathing during radiation

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital and Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prone Position with DIBH; For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board.	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.
Active Comparator: Supine Position with DIBH; For the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology.	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.
Active Comparator: Prone Position with no DIBH; For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board.	Other: Free breathing during radiation; The patient will be instructed to breathe freely.
Active Comparator: Supine Position with no DIBH; For the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology.	Other: Free breathing during radiation; The patient will be instructed to breathe freely.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Adam Currey, MD, PhD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Actual): March 21, 2021
• Study Completion (Actual): March 21, 2021

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: radiation; stage I; stage II; Deep Inspiration Breath Hold; stage IIa
• Additional Relevant MeSH Terms: Breast Carcinoma In Situ; Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Respiration Disorders; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Skin Diseases; Breast Diseases; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Carcinoma in Situ; Respiratory Aspiration; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: PRO00030436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No