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

January 26, 2026 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (Aquaphor)
Beginning on day 1 of radiation therapy, patients apply Aquaphor BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Apply to skin
Other Names:
  • Aquaphor
Experimental: Arm II (Miaderm)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Agent Affecting Integumentary System
Apply Miaderm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Radiation Dermatitis
Time Frame: Up to 120 days after completion of radiation therapy
Depending on prescribed duration of radiation treatment, each subject will contribute between 5 and 8 periodic assessments for the presence of acute radiation dermatitis Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC toxicity score of 2 or higher). The hypothesized association between randomized treatment and the repeated binary outcome of Acute Radiation Dermatitis will be tested using repeated measures logistic regression. That model will be implemented with PROC GENMOD (SAS software) for a generalized linear regression model with generalized estimating equation (GEE) for binary data with logit link function. In this way, the analysis will recognize the within-patient correlation inherent in repeated assessments.
Up to 120 days after completion of radiation therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QoL)
Time Frame: Up to 120 days after completion of radiation therapy
Skindex-16 is a single-page, validated measure of the effects of skin disease on patients' quality of life. The 16 questions address Symptoms (4 items), Emotions (7 items), and Functioning (5 items). Using a 7-level scale that is scored from 0 (Never bothered) to 100 (Always bothered), each question asks how much during the last 7 days the patient has been bothered by a specific aspect of their disease. Responses are averaged to generate a Global score and 3 domain-specific sub-scores, all ranging from 0 to 100, with higher scores indicating worse disease-related quality of life. Evaluated by the Skindex-16 questionnaire will be compared between the two study arms. T tests will be applied to assess mean differences between arms at each time point.
Up to 120 days after completion of radiation therapy
Supportive measures
Time Frame: Up to 120 days after completion of radiation therapy
Depending on prescribed duration of radiation treatment, each subject will contribute between 5 and 8 periodic assessments for the use of Concomitant Therapy for acute radiation dermatitis. The hypothesized association between randomized treatment and the repeated binary outcome of Concomitant Therapy will be tested using repeated measures logistic regression. Similar to the analysis of the Primary Endpoint described above, this model will be implemented with PROC GENMOD (SAS software) for a generalized linear regression model with GEE for binary data with logit link function and will consider potential covariates and possible treatment-by-time interaction as described above for the Primary Endpoint analysis.
Up to 120 days after completion of radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Scott M Glaser, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2022

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21152 (Other Identifier: City of Hope Medical Center)
  • P30CA043703 (U.S. NIH Grant/Contract)
  • NCI-2022-01957 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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