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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-21

Study Completion Date

2026-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Ductal Carcinoma In Situ Invasive Breast Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Intervention Type OTHER

Apply to skin

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Agent Affecting Integumentary System

Intervention Type DRUG

Apply Miaderm

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Agent Affecting Integumentary System

Apply Miaderm

Intervention Type DRUG

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Apply to skin

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Aquaphor Quality of Life Assessment

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No