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

Primary Purpose

Breast Cancer, Ductal Carcinoma in Situ, Invasive Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Inspiration Breath Hold during Radiation
Free breathing during radiation
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring radiation, Deep Inspiration Breath Hold, stage I, stage II, stage IIa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Froedtert Hospital and Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Prone Position with DIBH

Supine Position with DIBH

Prone Position with no DIBH

Supine Position with no DIBH

Arm Description

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

For the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology.

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

For the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Changes in left ventricular ejection fraction prior to, during or after radiation therapy.
This will be measured as a percentage.
Changes in left atrial volume prior to, during or after radiation therapy.
This will be measured in millimeters.
Left ventricular wall thickness prior to, during or after radiation therapy.
This will be measured in millimeters.
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.

Full Information

First Posted
December 13, 2017
Last Updated
August 1, 2022
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03375892
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2018 (Actual)
Primary Completion Date
March 21, 2021 (Actual)
Study Completion Date
March 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Ductal Carcinoma in Situ, Invasive Breast Cancer
Keywords
radiation, Deep Inspiration Breath Hold, stage I, stage II, stage IIa

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prone Position with DIBH
Arm Type
Active Comparator
Arm Description
For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board.
Arm Title
Supine Position with DIBH
Arm Type
Active Comparator
Arm Description
For the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology.
Arm Title
Prone Position with no DIBH
Arm Type
Active Comparator
Arm Description
For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board.
Arm Title
Supine Position with no DIBH
Arm Type
Active Comparator
Arm Description
For the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology.
Intervention Type
Other
Intervention Name(s)
Deep Inspiration Breath Hold during Radiation
Intervention Description
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
Intervention Name(s)
Free breathing during radiation
Intervention Description
The patient will be instructed to breathe freely.
Primary Outcome Measure Information:
Title
Changes in EKG parameters prior to, during or after radiation therapy.
Description
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.
Time Frame
Baseline, 6 weeks, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in mitochondrial energy production, as measured in leukocytes (peripheral blood mononuclear cells) from patients prior to and after undergoing radiation therapy.
Description
Mitochondrial energy production will be measured by determining oxygen consumption rate (pmol of O2 consumed per second per·10^6 cells).
Time Frame
baseline, 6 weeks, and 6 and 12 months post-radiation therapy
Title
Changes in left ventricular ejection fraction prior to, during or after radiation therapy.
Description
This will be measured as a percentage.
Time Frame
Baseline and 12 months
Title
Changes in left atrial volume prior to, during or after radiation therapy.
Description
This will be measured in millimeters.
Time Frame
Baseline and 12 months
Title
Left ventricular wall thickness prior to, during or after radiation therapy.
Description
This will be measured in millimeters.
Time Frame
Baseline and 12 months
Title
Arterial and aortic stiffness.
Description
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.
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Currey, MD, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Hospital and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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