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

NCT ID: NCT03375892

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-03
• Study Completion Date: 2021-03-21

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.

Conditions

Breast Cancer; Ductal Carcinoma in Situ; Invasive Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prone Position with DIBH

For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board.

Group Type: ACTIVE_COMPARATOR

Deep Inspiration Breath Hold during Radiation

Intervention Type: OTHER

The DIBH technique involves the patient breathing to a specified threshold and then holding that level of inspiration during every radiation therapy field delivered.

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.

Group Type: ACTIVE_COMPARATOR

Deep Inspiration Breath Hold during Radiation

Intervention Type: OTHER

The DIBH technique involves the patient breathing to a specified threshold and then holding that level of inspiration during every radiation therapy field delivered.

Prone Position with no DIBH

For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board.

Group Type: ACTIVE_COMPARATOR

Free breathing during radiation

Intervention Type: OTHER

The patient will be instructed to breathe freely.

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.

Group Type: ACTIVE_COMPARATOR

Free breathing during radiation

Intervention Type: OTHER

The patient will be instructed to breathe freely.

Interventions

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.

Intervention Type: OTHER

Free breathing during radiation

The patient will be instructed to breathe freely.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Adam Currey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam Currey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert Hospital and Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

PRO00030436

Identifier Type: -

Identifier Source: org_study_id