Breast NeoplasmsNCT03461588
Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer
A study testing free-breathing and deep inspiratory breath-holding in people with Breast Neoplasms and Heart Injuries, run by Shu lian Wang at 2 sites in China.
Trial summary
This study is to prospectively investigate the cardiac dose-sparing effect and clinical benefit of deep inspiration breath-hold (DIBH) technique. Patients with left-sided breast cancer treated with breast conserving surgery followed by radiotherapy is enrolled. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms, Heart Injuries, Radiation Toxicity
- What is being tested?
- free-breathing and deep inspiratory breath-holding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2017to 30 Jan 2020
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left-sided breast cancer
- Underwent breast conserving surgery
- Planned for postoperative whole breast +- regional nodal radiotherapy
- No basic heart disease
Who cannot join
- Abnormal cardiac baseline examination
- History of chest radiation
- Can not tolerate deep inspiratory breath-holding
Trial locations and contacts
2 sites in 1 country.
China2 sites
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Cancer Hosptical, Chinese Academy of Medical Sciences
Beijing, 100021
About this study
Official title: Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer Treated With Breast Conserving Surgery Followed by Radiotherapy With Free-breathing or Deep Inspiration Breath-hold (DIBH) Technique
This study is to prospectively investigate the cardiac dose-sparing effect and clinical benefit of deep inspiration breath-hold (DIBH) technique. Patients with left-sided breast cancer treated with breast conserving surgery followed by radiotherapy is enrolled. Radiotherapy is delivered with either free-breathing or deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters and cardiac toxicity are prospective evaluated, and the dose-effect relationship is analyzed.
Read the detailed description
Patients with left-sided breast cancer treated with breast conserving surgery are prospectively enrolled. Two types of radiation treatment are delivered based on attending physician's preferences: radiation to whole breast +- regional nodal areas with free-breathing technique, or with deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters including heart dose and the dose to left anterior coronary artery are assessed, and the cardiac toxicities regularly assessed with cardiac enzymes,electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging before, during and after radiation.The dose-effect relationship of heart injuries is analyzed.
- Conditions
- Breast Neoplasms, Heart Injuries, Radiation Toxicity
- Being tested
- free-breathing, deep inspiratory breath-holding
- Medical subject headings
- Breast Neoplasms, Heart Injuries, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free-breathingRadiation
patients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery
deep inspiratory breath-holdingRadiation
patients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery
| Study group | Role | What they receive |
|---|---|---|
| Free-breathing | Active comparator | standard treatment Receives: Radiation: free-breathing |
| Deep inspiratory breath-holding | Experimental | new technique Receives: Radiation: deep inspiratory breath-holding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0
The cardiac adverse events are regularly assessed with cardiac symptoms,cardiac enzymes(TnT，BNP),electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Jan 2017
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shu lian Wang
- Responsible party
- Sponsor-investigator, Shu lian Wang, Chinese Academy of Medical Sciences
- Investigators
- Shulian Wang, M.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461588
- Sponsor's protocol ID
- LC2016A09
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer Treated With Breast Conserving Surgery Followed by Radiotherapy With Free-breathing or Deep Inspiration Breath-hold (DIBH) Technique
- ClinicalTrials.gov ID
- NCT03461588
- Acronym / sponsor ID
- LC2016A09
- Conditions
- Breast Neoplasms, Heart Injuries, Radiation Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Shu lian Wang
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 12 Mar 2018 (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 is to prospectively investigate the cardiac dose-sparing effect and clinical benefit of deep inspiration breath-hold (DIBH) technique. Patients with left-sided breast cancer treated with breast conserving surgery followed by radiotherapy is enrolled. Radiotherapy is delivered with either free-breathing or deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters and cardiac toxicity are prospective evaluated, and the dose-effect relationship is analyzed.
Detailed description
Patients with left-sided breast cancer treated with breast conserving surgery are prospectively enrolled. Two types of radiation treatment are delivered based on attending physician's preferences: radiation to whole breast +- regional nodal areas with free-breathing technique, or with deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters including heart dose and the dose to left anterior coronary artery are assessed, and the cardiac toxicities regularly assessed with cardiac enzymes,electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging before, during and after radiation.The dose-effect relationship of heart injuries is analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free-breathing | Active comparator | Radiation: free-breathingstandard treatment |
| Deep inspiratory breath-holding | Experimental | Radiation: deep inspiratory breath-holdingnew technique |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Left-sided breast cancer
- Underwent breast conserving surgery
- Planned for postoperative whole breast +- regional nodal radiotherapy
- No basic heart disease
Key exclusion criteria (3 listed)
- Abnormal cardiac baseline examination
- History of chest radiation
- Can not tolerate deep inspiratory breath-holding
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 |
|---|---|---|
| free-breathingpatients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery | Radiation | Free-breathing |
| deep inspiratory breath-holdingpatients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery | Radiation | Deep inspiratory breath-holding |
Primary outcome
Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0
Time frame: up to 2 years
The cardiac adverse events are regularly assessed with cardiac symptoms,cardiac enzymes(TnT，BNP),electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging.
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 25 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Shulian Wang, M.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing free-breathing and deep inspiratory breath-holding in people with Breast Neoplasms and Heart Injuries, run by Shu lian Wang at 2 sites in China.
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 4 inclusion and 3 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0 (time frame: up to 2 years). 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 25 Mar 2020.