Back to resultsProspective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer
Primary Purpose
Breast Neoplasms, Heart Injuries, Radiation Toxicity
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
free-breathing
deep inspiratory breath-holding
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Left-sided breast cancer
- Underwent breast conserving surgery
- Planned for postoperative whole breast +- regional nodal radiotherapy
- No basic heart disease
Exclusion Criteria:
- Abnormal cardiac baseline examination
- History of chest radiation
- Can not tolerate deep inspiratory breath-holding
Sites / Locations
- Cancer Hospital, Chinese Academy of Medical Sciences
- Cancer Hosptical, Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Free-breathing
Deep inspiratory breath-holding
Arm Description
standard treatment
new technique
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03461588
Brief Title
Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shu lian Wang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Heart Injuries, Radiation Toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Free-breathing
Arm Type
Active Comparator
Arm Description
standard treatment
Arm Title
Deep inspiratory breath-holding
Arm Type
Experimental
Arm Description
new technique
Intervention Type
Radiation
Intervention Name(s)
free-breathing
Intervention Description
patients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery
Intervention Type
Radiation
Intervention Name(s)
deep inspiratory breath-holding
Intervention Description
patients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery
Primary Outcome Measure Information:
Title
Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0
Description
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.
Time Frame
up to 2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Left-sided breast cancer
Underwent breast conserving surgery
Planned for postoperative whole breast +- regional nodal radiotherapy
No basic heart disease
Exclusion Criteria:
Abnormal cardiac baseline examination
History of chest radiation
Can not tolerate deep inspiratory breath-holding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shulian Wang, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Cancer Hosptical, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer
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