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

Running, not enrolling · Phase 1

Conditions studied: Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT05340673

Run by

City of Hope Medical Center

People needed

208

Starts

2022-06-21

Expected to finish

2026-12-15

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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