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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Neoplasms Breast Diseases Heart Injuries Neoplasms Neoplasms by Site Radiation Injuries Radiation Toxicity Skin Diseases Skin and Connective Tissue Diseases Thoracic Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

free-breathing

Radiation

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

deep inspiratory breath-holding

Radiation

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

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shu lian Wang

Unknown

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Mar 12, 2018
Registry last updated: Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed