Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer

NCT05358093 | Unknown

• 1 other identifier: left breast cancer
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

45

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

female with left breast cancer

You may qualify if:

• \. 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

You may not qualify if:

• Patient \> 75 years old
• Non histological diagnosed
• Metastatic patient
• Patient with cardiac or other co morbidity.
• ECoG performance status \>2
• pregnant or lactating patients

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Related Info
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Central Study Contacts

Amira Hussien Ahmed, master

CONTACT

01018719085; hussienamira57@gmail.com

amira hussien, master degree

CONTACT

01018719085; hussienamira57@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: May 3, 2022
• Study Start: April 27, 2022
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share