Status:
RECRUITING
Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This pilot study will evaluate the feasibility of at least twice daily use of azelaic acid in breast cancer patients undergoing radiation treatment.
Detailed Description
Patients will use azelaic acid twice daily (morning and evening) beginning 1 week before radiation treatment, and will continue use until 3 weeks after completion of radiation treatment
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- 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 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
- Treatment plan includes one of the following:
- Conventionally fractionated whole breast radiation (45-50 Gray in 25 fractions)
- Moderately hypofractionated whole breast radiation (42.56 Gray in 16 fractions or 40 Gray in 15 fractions)
- Conventionally fractionated chest wall radiation (45-50 Gray in 25 fractions)
- Treatment of the regional lymph nodes, a tumor bed boost (4-8 fractions), and use of tissue-equivalent bolus on the chest wall may be included at the discretion of the treating physician.
- Radiation will be photon-based. Note: If the patient receives a boost, photons and/or electrons may be used at the discretion of the treating physician.
Exclusion
- 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
- Co-existing medical conditions resulting in life expectancy \< 1 years
- Active collagen vascular diseases (ie lupus erythematosus, scleroderma, dermatomyositis)
- History of organ transplant or bone marrow transplant
- History of hypersensitivity or allergic reaction to any ingredients in the topical azelaic acid formulation
- Has used within 1 month prior to baseline:
- topical retinoids to the breast
- oral retinoids
- systemic (oral or injectable) antibiotics known to have an impact on the severity of skin rash or sun-sensitivity (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim)
- systemic corticosteroids or immunosuppressive drugs
- Has used on treated breast within 2 weeks prior to baseline:
- topical corticosteroids
- topical antibiotics
- topical medications for skin rash (eg, metronidazole, azelaic acid)
- Radiation therapy will be proton therapy or carbon therapy
- External beam partial breast irradiation, brachytherapy partial breast irradiation, or intraoperative radiation are included in the treatment plan Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Key Trial Info
Start Date :
August 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06966388
Start Date
August 13 2025
End Date
November 30 2026
Last Update
August 17 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298