Azelaic Acid for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and practicality of using azelaic acid, a topical treatment, for breast cancer patients undergoing radiation therapy. The goal is to determine if applying azelaic acid twice daily can be easily integrated into their care routine. The trial seeks participants diagnosed with breast cancer who are receiving specific types of radiation treatments. It is particularly interested in individuals who identify as Black, Asian, Hispanic/Latin, or originate from regions like the Mediterranean or Pacific, and who tan easily in the sun. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this treatment.
Will I have to stop taking my current medications?
The trial requires you to stop using certain medications before starting. You must not have used topical retinoids, oral retinoids, certain antibiotics, or systemic corticosteroids within a month before the trial, and you must not have used topical corticosteroids or antibiotics on the treated breast within two weeks before the trial.
Is there any evidence suggesting that azelaic acid is likely to be safe for humans?
Research has shown that azelaic acid is usually safe for skin application. However, some individuals might experience mild irritation or a burning sensation. Previous studies have used azelaic acid to treat skin issues like acne and rosacea, demonstrating better results than a placebo.
This study is just beginning, with the main goal of assessing azelaic acid's safety for breast cancer patients, particularly those undergoing radiation treatment. As an early-phase trial, there is limited information on safety for this specific group. However, azelaic acid's approval for other uses suggests it is generally safe for skin application.
Prospective trial participants should be aware of the possibility of mild skin irritation. Consult a healthcare provider if there are any concerns.12345Why do researchers think this study treatment might be promising?
Azelaic Acid is unique because it is applied topically, unlike most standard breast cancer treatments, which often involve systemic chemotherapy or hormone therapy. This method could potentially target cancer cells directly on the skin with fewer side effects. Researchers are excited about Azelaic Acid's potential to provide a more localized and less invasive treatment option for breast cancer patients.
What evidence suggests that azelaic acid might be an effective treatment for breast cancer?
Research has shown that azelaic acid may help treat skin problems like acne. One study demonstrated that using a 15% azelaic acid cream twice a day significantly improved acne symptoms over nine months. Although this study focused on acne, it suggests that azelaic acid might also help with other skin issues. Additionally, azelaic acid can reduce swelling, which might help manage some side effects of radiation treatment in cancer patients. While direct evidence for its use in breast cancer is limited, these findings provide a reason to explore its potential in this trial, where participants will apply topical azelaic acid twice daily.36789
Who Is on the Research Team?
Todd C. Adams, MD
Principal Investigator
Virginia Commonwealth University
Are You a Good Fit for This Trial?
This trial is for breast cancer patients who are currently undergoing radiation therapy. The study aims to see if they can apply a topical treatment called Azelaic Acid at least twice daily without any issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Radiation Treatment
Participants begin using azelaic acid twice daily one week before radiation treatment
Radiation Treatment
Participants continue using azelaic acid twice daily during radiation treatment
Post-Radiation Treatment
Participants continue using azelaic acid twice daily for three weeks following radiation treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azelaic Acid
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor