Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

About this trial

This pilot study will evaluate the feasibility of at least twice daily use of azelaic acid in breast cancer patients undergoing radiation treatment.

Eligibility criteria

Qualifiers

Self-reports as Black, Asian, Hispanic/Latin, ethnically originating from the Mediterranean rim or Pacific rim, or she/he tans easily in the sun

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 1, Section 18)

Attestation by the patient that she/he is not pregnant, lactating, or planning to become pregnant, or planning to father a baby during the study period

Histologic confirmation of breast malignancy (with TNM staging) If the patient did not receive adjuvant chemotherapy, adjuvant radiation must start within 180 days of lumpectomy or mastectomy. If the patient received adjuvant chemotherapy, adjuvant radiation should start within 60 days of the last dose of chemotherapy

Disqualifiers

Prior radiotherapy to any portion of the planned treatment site

Current inflammatory breast cancer or gross dermal involvement at initiation of radiotherapy

Concomitant immunotherapy or cytotoxic chemotherapy. Concomitant HER2 directed therapy or concomitant endocrine therapy is allowed

Active rash or dermatitis within the treatment field, or a history of any rash or dermatologic condition within the treatment field

Trial design

Treatments tested in this trial

  • Azelaic Acid

Treatment groups

33 Participants
are divided into 1 treatment group