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Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05358093
Collaborator
(none)
45
Enrollment
19.1
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    45 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Study of Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer
    Anticipated Study Start Date :
    Apr 27, 2022
    Anticipated Primary Completion Date :
    Oct 30, 2023
    Anticipated Study Completion Date :
    Nov 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    45

    Outcome Measures

    Primary Outcome Measures

    1. retrospective study of cardiac toxicity in left breast cancer received hypofractionated radiotherapy [baseline]

      detection of toxicity on cardiac ejection fraction in 45 patients received hypofractionated radiotherapy over left breast

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amira Hussien Ahmed Hussien, principle investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05358093
    Other Study ID Numbers:
    • left breast cancer
    First Posted:
    May 3, 2022
    Last Update Posted:
    May 3, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Cardiotoxicity

    Study Results

    No Results Posted as of May 3, 2022