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

Virginia Commonwealth University (VCU)

Status and phase

Begins enrollment in 3 months

Phase 1

Conditions

Breast Cancer

Treatments

Drug: Azelaic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT06966388

MCC-23-20546

Details and patient eligibility

About

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

Full 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

Enrollment

33 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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