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

Invasive Breast Carcinoma Clinical Trial

Official title:

A Randomized Clinical Trial Comparing Supplemental Topical Treatments for Acute Radiation Dermatitis in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340673
• Other study ID #: 21152
• Secondary ID: NCI-2022-0195721
• Status: Recruiting
• Phase: Phase 1
• Start date: June 21, 2022
• Est. completion date: June 21, 2024

Study information

• Verified date: June 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 21, 2024
• Est. primary completion date: June 21, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Ductal Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Dermatitis
• Invasive Breast Carcinoma
• Radiodermatitis

Intervention

Drug:
• Agent Affecting Integumentary System
Apply Miaderm

Other:
• Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Apply to skin
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life (QoL)	Skindex-16 is a single-page, validated measure of the effects of skin disease on patients' quality of life. The 16 questions address Symptoms (4 items), Emotions (7 items), and Functioning (5 items). Using a 7-level scale that is scored from 0 (Never bothered) to 100 (Always bothered), each question asks how much during the last 7 days the patient has been bothered by a specific aspect of their disease. Responses are averaged to generate a Global score and 3 domain-specific sub-scores, all ranging from 0 to 100, with higher scores indicating worse disease-related quality of life. Evaluated by the Skindex-16 questionnaire will be compared between the two study arms. T tests will be applied to assess mean differences between arms at each time point.	Up to 120 days after completion of radiation therapy
Secondary	Supportive measures	Depending on prescribed duration of radiation treatment, each subject will contribute between 5 and 8 periodic assessments for the use of Concomitant Therapy for acute radiation dermatitis. The hypothesized association between randomized treatment and the repeated binary outcome of Concomitant Therapy will be tested using repeated measures logistic regression. Similar to the analysis of the Primary Endpoint described above, this model will be implemented with PROC GENMOD (SAS software) for a generalized linear regression model with GEE for binary data with logit link function and will consider potential covariates and possible treatment-by-time interaction as described above for the Primary Endpoint analysis.	Up to 120 days after completion of radiation therapy