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

Shu lian Wang

Status: Completed

Conditions: Radiation Toxicity; Breast Neoplasms; Heart Injuries

Treatments: Radiation: deep inspiratory breath-holding; Radiation: free-breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT03461588

LC2016A09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Free-breathing

Active Comparator group

Description:

standard treatment

Treatment:

Radiation: free-breathing

Deep inspiratory breath-holding

Experimental group

Description:

new technique

Treatment:

Radiation: deep inspiratory breath-holding