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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05200078
Other study ID # 2020-2-4023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date June 30, 2023

Study information

Verified date January 2022
Source Chinese Academy of Medical Sciences
Contact Shu-Lian Wang
Phone 86-13366191993
Email wangsl@cicams.ac.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. This study aims to prospectively detect and predict early clinical or subclinical cardiac events in women undergoing adjuvant RT for breast cancer.


Description:

Women with left-sided breast cancer undergo hypofractionated RT at either free-breathing or deep inspiration breath-hold. The incidence and potential clinical, dosimetric and biological indicators of early clinical or subclinical cardiac injury are investigate at 2 years.


Recruitment information / eligibility

Status Recruiting
Enrollment 166
Est. completion date June 30, 2023
Est. primary completion date June 30, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Primary left-sided breast cancer post surgery - Planning for adjuvant breast/chest wall +-RNI Exclusion Criteria: - History of cardiovascular disease - Previous chest radiation - Bilateral breast cancers

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Deep inspiration breath-hold technique
Selective application of deep inspiration breath-hold technique

Locations

Country Name City State
China Cancer Hospital, 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 Incidence of clinical or subclinical cardiac injury predefined cardiac events two years
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