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

NCT05340673 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 21152NCI-2022-01957P30CA043703
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Ductal Carcinoma In Situ; Invasive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Acute Radiation Dermatitis

  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 Outcomes (2)

• Quality of life (QoL)

  Up to 120 days after completion of radiation therapy

• Supportive measures

  Up to 120 days after completion of radiation therapy

Study Arms (2)

Arm I (Aquaphor)

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.

Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (Miaderm)

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.

Drug: Agent Affecting Integumentary System; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Agent Affecting Integumentary System DRUG

Apply Miaderm

Arm II (Miaderm)

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment OTHER

Apply to skin

Also known as: Aquaphor

Arm I (Aquaphor)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (Aquaphor); Arm II (Miaderm)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Aquaphor); Arm II (Miaderm)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Scott M Glaser

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 22, 2022
• Study Start: June 21, 2022
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)