Azelaic Acid for Breast Cancer

Overseen By Massey IIT Research Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Virginia Commonwealth University

Must not be taking: Immunotherapy, Cytotoxic chemotherapy, Retinoids, others

Disqualifiers: Inflammatory breast cancer, Rash, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

33 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Todd C. Adams, MD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

I am able to get out of my bed or chair and move around.

My radiation therapy will start soon after my chemotherapy.

My breast cancer has been confirmed and staged.

Exclusion Criteria

I have had radiation therapy on the area to be treated.

I currently have or have had a rash or skin condition in the area to be treated.

I have an active collagen vascular disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Radiation Treatment

Participants begin using azelaic acid twice daily one week before radiation treatment

1 week

Radiation Treatment

Participants continue using azelaic acid twice daily during radiation treatment

Up to 5 weeks

Weekly visits (in-person)

Post-Radiation Treatment

Participants continue using azelaic acid twice daily for three weeks following radiation treatment

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Azelaic Acid

Trial Overview The intervention being studied is the application of Azelaic Acid, which participants will use at least two times a day during their course of radiation treatment for breast cancer.

Participant Groups

Group I: Topical Azelaic Acid Experimental Treatment 1 Intervention

Twice daily application of azelaic acid

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+