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

NCT ID: NCT03461588

Last Updated: 2020-03-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-01-30

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms Heart Injuries Radiation Toxicity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Free-breathing

standard treatment

Group Type ACTIVE_COMPARATOR

free-breathing

Intervention Type RADIATION

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

Deep inspiratory breath-holding

new technique

Group Type EXPERIMENTAL

deep inspiratory breath-holding

Intervention Type RADIATION

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

Interventions

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free-breathing

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

Intervention Type RADIATION

deep inspiratory breath-holding

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

Intervention Type RADIATION

Eligibility Criteria

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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
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 of medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shulian Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Cancer Hosptical, Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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LC2016A09

Identifier Type: -

Identifier Source: org_study_id

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