Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2023-09-07
• Target enrollment: 0
• Participant gender: Female

Summary

This clinical trial compares two supplemental topical agents (Aquaphor and Miaderm) for the treatment of acute radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a radiation-induced skin reaction which can cause itching, swelling, pain, and general discomfort. Aquaphor is a commonly available, inexpensive, petrolatum-based multi-purpose ointment designed to protect and sooth extremely dry skin, chapped lips, cracked hands and feet, minor cuts and burns, and many other skin irritations. Miaderm is a water-based cream and contains ingredients like calendula, hyaluronate, and aloe vera which may help reduce occurrence and severity of radiation dermatitis. Both are commonly recommended and used by breast cancer patients undergoing external beam radiation therapy (EBRT). However, it is not known whether one is better than the other in treating or preventing radiation dermatitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Mineral Oil; Petrolatum

Criteria

Inclusion Criteria:

• Documented informed consent of the participant and/or legally authorized representative.

• Age > 18 years.

• Undergoing external beam radiation therapy (EBRT) to the breast or chest wall following surgical resection (lumpectomy or mastectomy) for ductal carcinoma in situ (DCIS) or invasive breast cancer using either conventional fractionation or hypofractionation.

Exclusion Criteria:

• Partial breast irradiation.

• Prior radiation overlapping with the intended radiotherapy field.

• History of systemic radiation sensitivity diseases (xeroderma pigmentosum, ataxia telangiectasia).

• Extreme hypofractionation (less than 15 fractions of radiation).

• Palliative treatment.

• Patient intention to use topical product other than Aquaphor or Miaderm.

• Inflammatory breast cancer, skin involvement, planned use of bolus.