NCT05340673

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

A Randomized Clinical Trial Comparing Supplemental Topical Treatments for Acute Radiation Dermatitis in Breast Cancer Patients

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Determine the efficacy of Miaderm compared to Aquaphor in the treatment and/or prevention of radiation dermatitis caused by EBRT in breast cancer patients undergoing EBRT to the breast/chest wall. SECONDARY OBJECTIVE: I. Determine quality of life (QoL) and need for additional concomitant therapies to address dermatitis in breast cancer patients undergoing EBRT to the breast/chest wall using Miaderm compared to Aquaphor. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Beginning on day 1 of radiation therapy, patients apply Aquaphor twice daily (BID), but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT. ARM II: Beginning on day 1 of radiation therapy, patients apply Miaderm BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT. After completion of study treatment, patients are followed up at 2 weeks and then at 90-120 days.

Conditions

• Breast Ductal Carcinoma In Situ
• Invasive Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Agent Affecting Integumentary System	Apply Miaderm
OTHER	Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment	Apply to skin
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2022-06-21
• Primary completion: 2026-12-15
• Completion: 2026-12-15
• First posted: 2022-04-22
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study