Breast CancerNCT01849614
Assessment of Ability of Breath Hold for Left-sided Breast Cancer Radiation Therapy to Reduce Side Effects to Heart
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cardiac SPECT perfusion scan
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2016
- Phase
- Observational
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with left-sided breast cancer
Who may be able to join
- signed an Institutional Review Board (IRB)-approved informed consent document for protocol
- age >= 18 years
- histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy
- stage 0-III left-sided breast cancer (including DCIS)
- SPECT score of 0 at baseline
- radiation oncologist agrees target volume coverage will not be compromised via use of the DIBH technique along with conformal field shaping
Who cannot join
- active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
- symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
- concurrent chemotherapy
- prior receipt of mediastinal radiation therapy
- pregnant or lactating women
- inability to understand and follow breathing instructions for the DIBH procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
About this study
Official title: Prospective Pilot Study of Assessment of Breath Hold as a Means to Mitigate the Risk of Radiation-associated Reductions in Regional Cardiac Perfusion in Patients With Left-sided Breast Cancer
The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart.
Read the detailed description
The primary objective of this study is to estimate the rate of radiation-associated regional myocardial perfusion defects in patients 6 months after breast/chestwall radiation with DIBH for left-sided breast cancer. Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation.
- Conditions
- Breast Cancer
- Being tested
- Cardiac SPECT perfusion scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SPECT perfusion scanOther
A SPECT cardiac perfusion scan provides a three-dimensional map of blood flow to the heart tissue. The scan will be taken at rest only.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Women with left-sided breast cancer Receives: Other: Cardiac SPECT perfusion scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiac perfusion
Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation. Any post-radiation summed-rest score (SRS) > 0 will be counted as a perfusion defect in the calculation of the perfusion defect rate.
Measured: 6-months post radiation
Secondary outcomes (1)
Wall-motion abnormalities
The incidence of wall-motion abnormalities will be assessed using SPECT in the same 12 segment scoring system used to quantify perfusion. Wall-motion abnormalities will be recorded as present or absent in each cardiac segment. When present, wall-motion abnormalities wil be classified as gypokinetic, akinetic, or dyskinetic. The extent of wall involvement (small or large portion) will be described as mild or severe.
Measured: 6-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionMar 2016
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 UNC Lineberger Comprehensive Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy M Zagar, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849614
- Sponsor's protocol ID
- LCCC1239
- Status last verified
- May 2016
- First submitted
- 3 May 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study of Assessment of Breath Hold as a Means to Mitigate the Risk of Radiation-associated Reductions in Regional Cardiac Perfusion in Patients With Left-sided Breast Cancer
- ClinicalTrials.gov ID
- NCT01849614
- Acronym / sponsor ID
- LCCC1239
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 May 2013 (estimated)
- 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.
The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart.
Detailed description
The primary objective of this study is to estimate the rate of radiation-associated regional myocardial perfusion defects in patients 6 months after breast/chestwall radiation with DIBH for left-sided breast cancer. Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Other: Cardiac SPECT perfusion scanWomen with left-sided breast cancer |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with left-sided breast cancer
Key inclusion criteria (6 listed)
- signed an Institutional Review Board (IRB)-approved informed consent document for protocol
- age >= 18 years
- histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy
- stage 0-III left-sided breast cancer (including DCIS)
- SPECT score of 0 at baseline
Key exclusion criteria (6 listed)
- active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
- symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
- concurrent chemotherapy
- prior receipt of mediastinal radiation therapy
- pregnant or lactating women
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 |
|---|---|---|
| Cardiac SPECT perfusion scanA SPECT cardiac perfusion scan provides a three-dimensional map of blood flow to the heart tissue. The scan will be taken at rest only. | Other | Patient group |
Primary outcome
Changes in cardiac perfusion
Time frame: 6-months post radiation
Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation. Any post-radiation summed-rest score (SRS) > 0 will be counted as a perfusion defect in the calculation of the perfusion defect rate.
1 secondary outcome
Wall-motion abnormalities
Time frame: 6-months post-treatment
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 12 May 2016.
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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.
Timothy M Zagar, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 6 inclusion and 6 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 12 May 2016. 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 cardiac perfusion (time frame: 6-months post radiation). 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 12 May 2016.