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

NCT03375892 | Completed DMC

• 1 other identifier: PRO00030436
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Ductal Carcinoma in Situ; Invasive Breast Cancer

Keywords

radiation; Deep Inspiration Breath Hold; stage I; stage II; stage IIa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Changes in left ventricular ejection fraction prior to, during or after radiation therapy.

  Baseline and 12 months

• Changes in left atrial volume prior to, during or after radiation therapy.

  Baseline and 12 months

• Left ventricular wall thickness prior to, during or after radiation therapy.

  Baseline and 12 months

• Arterial and aortic stiffness.

  Baseline and 12 months

Study Arms (4)

Prone Position with DIBH

ACTIVE COMPARATOR

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

Other: Deep Inspiration Breath Hold during Radiation

Supine Position with DIBH

ACTIVE COMPARATOR

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

Prone Position with no DIBH

ACTIVE COMPARATOR

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

Other: Free breathing during radiation

Supine Position with no DIBH

ACTIVE COMPARATOR

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

Interventions

Deep Inspiration Breath Hold during Radiation 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 DIBH; Supine Position with DIBH

Free breathing during radiation OTHER

The patient will be instructed to breathe freely.

Prone Position with no DIBH; Supine Position with no DIBH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital and Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Adam Currey, MD, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 18, 2017
• Study Start: March 3, 2018
• Primary Completion: March 21, 2021
• Study Completion: March 21, 2021
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)