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Determining Molecular Drivers of Radiation Dermatitis

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04764682
Collaborator
(none)
20
Enrollment
1
Location
24.6
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being conducted to address key gaps in current knowledge and set the stage for rational design of strategies to prevent (pre-exposure to radiation), mitigate (post-exposure to radiation before overt signs/symptoms appear), and/or treat (post-onset of signs/symptoms) radiation dermatitis (itchy, dry skin or a rash on swollen, reddened skin).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Determining Molecular Drivers of Radiation Dermatitis
    Actual Study Start Date :
    Feb 10, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Change in skin [Baseline, final week of radiation]

      A skin punch biopsy will be obtained from a visible area of skin that harbors signs of clinical radiation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients receiving standard-of-care postoperative radiation therapy (2-2.7 Gy per fraction) to the breast and/or chest wall for breast cancer treatment.

    • Tissue diagnosis of breast cancer.

    • Age > 18 years

    • Signed informed consent.

    • Complete blood count within normal limits within the preceding 2 weeks.

    Exclusion criteria:

    • Induction chemotherapy or biologic therapy

    • Concurrent chemotherapy or biologic therapy

    • Autoimmune disease with skin manifestations - psoriasis, dermatomyositis, scleroderma, eczema, polymyositis

    • Allergy to lidocaine anesthesia

    • Known bleeding diathesis (anticoagulation with warfarin, coagulation/bleeding disorders, vitamin C or K deficiency, thrombocytopenia)

    • History of keloids or easy scarring

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Laura Vallow, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Laura A. Vallow, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04764682
    Other Study ID Numbers:
    • 19-005445
    First Posted:
    Feb 21, 2021
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dermatitis
    Radiodermatitis

    Study Results

    No Results Posted as of Mar 3, 2022