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

City of Hope

Status and phase: Active, not recruiting; Phase 1

Conditions: Invasive Breast Carcinoma; Breast Ductal Carcinoma In Situ

Treatments: Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Drug: Agent Affecting Integumentary System; Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05340673

NCI-2022-01957 (Registry Identifier)

21152

P30CA043703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Arm I (Aquaphor)

Experimental group

Description:

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.

Treatment:

Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Arm II (Miaderm)

Experimental group

Description:

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.

Treatment:

Drug: Agent Affecting Integumentary System

Other: Quality-of-Life Assessment

Other: Questionnaire Administration