Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer

NCT ID: NCT05358093

Last Updated: 2022-05-03

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

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-27

Study Completion Date

2023-11-30

Brief Summary

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Worldwide, Breast cancer is the most common cancer in women,where 1.7 million new cases diagnosed in 2012 . In 2020 number doubled as 2.3 million women diagnosed with breast cancer. According to ACS 1 in 8 women in United states will develop breast cancer in her life .

Similarly again, In Egypt breast cancer is the most common malignancy in women about 22,700 new cases recorded in 2020. Accounting for 38.8% of cancers in this population and forecasted to be approximately 46,000 in 2050 .

Post-operative radiotherapy is fundamental part of treatment after either conservative surgery or mastectomy . Conventionally fractionated radiation therapy (CFRT) ,Delivering 45-50 GY in 1.8-2 GY daily fractions for 5 days per week over 5-7 weeks was the standard schedule to eradicate sub clinical disease ,sparing normal tissues .After the publication of long term results of randomized controlled trials (RCTs) comparing safety and effectiveness of hypo fractionated RT (HFRT)delivered in3 weeks ,vs. CFRT in node negative BC has been implemented . in 2008 numerous international guidelines recommended HFRT as the new standard being Cost effectiveness ,limited resources ,excessively long RT waiting lists ,Another important argument for HFRT utilization ,even assuming alpha/beta of 1.5GY ,is biologically milder or isoeffective for healthy tissues compered to CFRT .

Cardiac toxicity is potentially long or short term complication of various anticancer therapies systemic therapy as anthracyclines or biological agent implicated in causing irreversible cardiac dysfunction.

Radiotherapy also have cardio toxic effect through different mechanisms

Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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45

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 1\. Age 18-75 years old 2. histopathology diagnosed 3. Left sided breast cancer 4. Receiving 3D hypofractionated radiotherapy 5. Patients should be non metastatic 6. performance status 0-2

Exclusion Criteria

* • Patient \> 75 years old

* Non histological diagnosed
* Metastatic patient
* Patient with cardiac or other co morbidity.
* ECoG performance status \>2
* pregnant or lactating patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amira Hussien Ahmed Hussien

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amira Hussien Ahmed, master

Role: CONTACT

01018719085

amira hussien, master degree

Role: CONTACT

01018719085

Related Links

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Other Identifiers

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left breast cancer

Identifier Type: -

Identifier Source: org_study_id

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