Status:
ACTIVE_NOT_RECRUITING
Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Ductal Carcinoma In Situ
Invasive Breast Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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. Radiati...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2025
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT05340673
Start Date
June 21 2022
End Date
December 21 2025
Last Update
August 5 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010