Clinical trial NCT05340673: Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer
Official title: A Randomized Clinical Trial Comparing Supplemental Topical Treatments for Acute Radiation Dermatitis in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Breast Ductal Carcinoma In Situ
Invasive Breast Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-04-22
Enrollment: 208
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute Radiation Dermatitis
timeFrame: Up to 120 days after completion of radiation therapy
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: Up to 120 days after completion of radiation therapy
measure: Supportive measures
timeFrame: Up to 120 days after completion of radiation therapy
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Scott M Glaser
role: PRINCIPAL_INVESTIGATOR
References: