Breast CancerNCT03375892
The Use of Deep Inspiration Breath Hold and Prone Irradiation to Decrease Cardiac Radiation Exposure
A study testing Deep Inspiration Breath Hold during Radiation and Free breathing during radiation in people with Breast Cancer and Ductal Carcinoma in Situ, run by Medical College of Wisconsin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Ductal Carcinoma in Situ, Invasive Breast Cancer
- What is being tested?
- Deep Inspiration Breath Hold during Radiation and Free breathing during radiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2018to 21 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: 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.
Read the 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.
- Being tested
- Deep Inspiration Breath Hold during Radiation, Free breathing during radiation
- Keywords
- radiation, Deep Inspiration Breath Hold, stage I, stage II, stage IIa
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Inspiration Breath Hold during RadiationOther
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 radiationOther
The patient will be instructed to breathe freely.
| Study group | Role | What they receive |
|---|---|---|
| Prone Position with DIBH | Active comparator | For prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Free breathing during radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Mitochondrial energy production will be measured by determining oxygen consumption rate (pmol of O2 consumed per second per·10^6 cells).
Measured: 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.
Measured: Baseline and 12 months
Changes in left atrial volume prior to, during or after radiation therapy.
This will be measured in millimeters.
Measured: Baseline and 12 months
Left ventricular wall thickness prior to, during or after radiation therapy.
This will be measured in millimeters.
Measured: 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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start3 Mar 2018
- Primary completion21 Mar 2021
- Study completion21 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Currey, Medical College of Wisconsin
- Investigators
- Adam Currey, MD, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375892
- Sponsor's protocol ID
- PRO00030436
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2017
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Use of Deep Inspiration Breath Hold and Prone Irradiation to Decrease Cardiac Radiation Exposure
- ClinicalTrials.gov ID
- NCT03375892
- Acronym / sponsor ID
- PRO00030436
- Keywords
- radiation, Deep Inspiration Breath Hold, stage I, stage II, stage IIa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 21 Mar 2021 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prone Position with DIBH | Active comparator | Other: Deep Inspiration Breath Hold during RadiationFor prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board. |
| Supine Position with DIBH | Active comparator | Other: Deep Inspiration Breath Hold during RadiationFor the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology. |
| Prone Position with no DIBH | Active comparator | Other: Free breathing during radiationFor prone positioning, patients will be positioned with alpha cradle casts, and a prone breast board. |
| Supine Position with no DIBH | Active comparator | Other: Free breathing during radiationFor the supine positioning, patients will be positioned with the breast board currently in use in the Department of Radiation Oncology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Inspiration Breath Hold during RadiationThe DIBH technique involves the patient breathing to a specified threshold and then holding that level of inspiration during every radiation therapy field delivered. | Other | Prone Position with DIBH, Supine Position with DIBH |
| Free breathing during radiationThe patient will be instructed to breathe freely. | Other | Prone Position with no DIBH, Supine Position with no DIBH |
Primary outcome
Changes in EKG parameters prior to, during or after radiation therapy.
Time frame: Baseline, 6 weeks, 6 months and 12 months
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.
5 secondary outcomes
Change in mitochondrial energy production, as measured in leukocytes (peripheral blood mononuclear cells) from patients prior to and after undergoing radiation therapy.
Time frame: baseline, 6 weeks, and 6 and 12 months post-radiation therapy
Changes in left ventricular ejection fraction prior to, during or after radiation therapy.
Time frame: Baseline and 12 months
Changes in left atrial volume prior to, during or after radiation therapy.
Time frame: Baseline and 12 months
Left ventricular wall thickness prior to, during or after radiation therapy.
Time frame: Baseline and 12 months
Arterial and aortic stiffness.
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Currey, MD, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Inspiration Breath Hold during Radiation and Free breathing during radiation in people with Breast Cancer and Ductal Carcinoma in Situ, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in EKG parameters prior to, during or after radiation therapy. (time frame: Baseline, 6 weeks, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.