RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-08-13

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06966388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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

Inclusion Criteria

Exclusion Criteria

* 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.

* 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

Contacts and Locations

Study Contact

Massey IIT Research Operations

CONTACT

804-628-6430

masseyepd@vcu.edu

Principal Investigator

Todd C. Adams, MD

PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

Todd C. Adams, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-13

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2025-08-13

Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer