Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer
1 other identifier
interventional
140
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 26, 2018
CompletedFirst Posted
Study publicly available on registry
March 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedMarch 25, 2020
March 1, 2020
3.1 years
February 26, 2018
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
up to 2 years
Study Arms (2)
Free-breathing
ACTIVE COMPARATORstandard treatment
Deep inspiratory breath-holding
EXPERIMENTALnew technique
Interventions
patients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery
patients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery
Eligibility Criteria
You may qualify if:
- Left-sided breast cancer
- Underwent breast conserving surgery
- Planned for postoperative whole breast +- regional nodal radiotherapy
- No basic heart disease
You may not qualify if:
- Abnormal cardiac baseline examination
- History of chest radiation
- Can not tolerate deep inspiratory breath-holding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shu lian Wanglead
Study Sites (2)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
Cancer Hosptical, Chinese Academy of Medical Sciences
Beijing, 100021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shulian Wang, M.D.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- UNKNOWN
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor of medicine
Study Record Dates
First Submitted
February 26, 2018
First Posted
March 12, 2018
Study Start
January 1, 2017
Primary Completion
January 30, 2020
Study Completion
January 30, 2020
Last Updated
March 25, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share