Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer

Breast Cancer Female Clinical Trial

Official title:

Retrospective Study of Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05358093
• Other study ID #: left breast cancer
• Status: Not yet recruiting
• Start date: April 27, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: Amira Hussien Ahmed, master
• Phone: 01018719085
• Email: hussienamira57[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: November 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Cardiotoxicity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retrospective study of cardiac toxicity in left breast cancer received hypofractionated radiotherapy	detection of toxicity on cardiac ejection fraction in 45 patients received hypofractionated radiotherapy over left breast	baseline

External Links

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