Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03461588

Enrollment

140

Registered

2018-03-12

Start date

2017-01-01

Completion date

2020-01-30

Last updated

2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Heart Injuries, Radiation Toxicity

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.

Interventions

RADIATIONfree-breathing

patients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery

RADIATIONdeep inspiratory breath-holding

patients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Left-sided breast cancer 2. Underwent breast conserving surgery 3. Planned for postoperative whole breast +- regional nodal radiotherapy 4. No basic heart disease

Exclusion criteria

1. Abnormal cardiac baseline examination 2. History of chest radiation 3. Can not tolerate deep inspiratory breath-holding

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026