Suspended

Miaderm vs Aquaphor for Radiation Dermatitis in Breast Cancer Patients

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Study Aim

This study aims to compare the effectiveness of Miaderm and Aquaphor in managing acute radiation dermatitis in breast cancer patients undergoing radiation therapy, by assessing the presence of skin reactions over the course of the treatment.

What is being tested

Agent Affecting Integumentary System

+ Quality-of-Life Assessment

+ Questionnaire Administration

DrugOther
Who is being recruted

Breast Carcinoma In Situ+6

+ Adenocarcinoma

+ Carcinoma

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 1
Interventional
Study Start: June 2022
See protocol details

Summary

Principal SponsorCity of Hope Medical Center
Last updated: January 29, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 21, 2022

Actual date on which the first participant was enrolled.

This clinical trial aims to compare the effectiveness of two topical treatments, Miaderm and Aquaphor, in managing radiation dermatitis. Radiation dermatitis is a common side effect experienced by breast cancer patients undergoing external beam radiation therapy (EBRT) to the breast or chest wall. The study's primary goal is to determine which of these two treatments is more effective in preventing or treating this condition. The trial is particularly important as it could help improve the quality of life for breast cancer patients undergoing radiation therapy, by identifying a more effective treatment for radiation dermatitis. Participants in this study are randomly assigned to one of two groups. The first group applies Aquaphor twice daily, starting from the first day of radiation therapy, to the area receiving radiation, with the exception of the four hours before treatment. This continues until two weeks after the completion of radiation therapy. The second group follows the same procedure but uses Miaderm instead of Aquaphor. After the completion of the treatment, patients are followed up at two weeks and then between 90 to 120 days. The study measures the effectiveness of these treatments by assessing the presence of acute radiation dermatitis using the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC toxicity score). The analysis will take into account the repeated assessments for each patient to understand the association between the treatment and the outcome.

Official TitleA Randomized Clinical Trial Comparing Supplemental Topical Treatments for Acute Radiation Dermatitis in Breast Cancer Patients
NCT05340673
Principal SponsorCity of Hope Medical Center
Last updated: January 29, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

208 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast Carcinoma In SituAdenocarcinomaCarcinomaCarcinoma in SituCarcinoma, Intraductal, NoninfiltratingNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and Medullary

Criteria

3 inclusion criteria required to participate
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.

7 exclusion criteria prevent from participating
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).

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

City of Hope Medical Center

Duarte, United StatesOpen City of Hope Medical Center in Google Maps
SuspendedOne Study Center