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

Not Applicable

Completed

• Conditions: Heart Injuries; Radiation Toxicity; Breast Neoplasms
• Interventions: Radiation: free-breathing; Radiation: deep inspiratory breath-holding

• Registration Number: NCT03461588
• Lead Sponsor: Shu lian Wang

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-12
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free-breathing	free-breathing	standard treatment
Deep inspiratory breath-holding	deep inspiratory breath-holding	new technique

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Cancer Hosptical, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China