Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer

NCT ID: NCT05200078

Last Updated: 2022-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Cardiac Event

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Radiotherapy at free-breathing

breast/chest wall+-RNI 43.5Gy/15f/3w(tumor bed 49.5Gy/15f/3w) delivered at free-breathing

No interventions assigned to this group

Radiotherapy at deep inspiration breath-hold

breast/chest wall+-RNI 43.5Gy/15f/3w(tumor bed 49.5Gy/15f/3w) delivered at deep inspiration breath-hold

Deep inspiration breath-hold technique

Intervention Type DEVICE

Selective application of deep inspiration breath-hold technique

Interventions

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Deep inspiration breath-hold technique

Selective application of deep inspiration breath-hold technique

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shu lian Wang

UNKNOWN

Sponsor Role lead

Responsible Party

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Shu lian Wang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shu-Lian Wang

Role: CONTACT

86-13366191993

Facility Contacts

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Shu-Lian Wang

Role: primary

8610-87787659

Other Identifiers

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2020-2-4023

Identifier Type: -

Identifier Source: org_study_id

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