Determining Molecular Drivers of Radiation Dermatitis

Breast Cancer Clinical Trial

Official title:

Determining Molecular Drivers of Radiation Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04764682
• Other study ID #: 19-005445
• Status: Active, not recruiting
• Start date: February 21, 2021
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Dermatitis
• Radiodermatitis

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in skin	A skin punch biopsy will be obtained from a visible area of skin that harbors signs of clinical radiation.	Baseline, final week of radiation