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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461588
• Other study ID #: LC2016A09
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: March 2020
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Heart Injuries
• Radiation Toxicity
• Wounds and Injuries

Intervention

Radiation:
• free-breathing
patients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery
• deep inspiratory breath-holding
patients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing
China	Cancer Hosptical, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shu lian Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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