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

  • End date
    Sep 7, 2023
  • participants needed
  • sponsor
    City of Hope Medical Center
Updated on 4 October 2022
breast cancer
carcinoma in situ
invasive breast cancer


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.



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.


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.

Condition Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Treatment questionnaire administration, quality-of-life assessment, Agent Affecting Integumentary System, Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Clinical Study IdentifierNCT05340673
SponsorCity of Hope Medical Center
Last Modified on4 October 2022


Yes No Not Sure

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
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