This randomized phase II trial studies curcumin to determine if it can clear human papillomavirus (HPV) infection or mild abnormal cells of the cervix in the treatment of patients with cervical intraepithelial neoplasia. These abnormal cells of the cervix are considered precancerous cells. Both invasive cervical cancers and precancerous cells have been firmly associated with the presence of high-risk HPV deoxyribonucleic acid (DNA). Not all precancerous cells progress to cancer. Curcumin, an extract from turmeric, a popular culinary spice, has been used in traditional Indian medicine for its anti-inflammatory and anti-infectious properties. Curcumin may slow down, destroy or prevent the growth of precancerous or cancer cells.
Additional locations may be listed on ClinicalTrials.gov for NCT04266275.
Locations matching your search criteria
United States
Georgia
Atlanta
Grady Health SystemStatus: Approved
Contact: Lisa C. Flowers
Phone: 404-778-1380
PRIMARY OBJECTIVE:
I. To determine if intravaginal curcumin will have higher rates of HPV clearance at 6 months compared to placebo in human immunodeficiency virus (HIV)-uninfected and infected women.
SECONDARY OBJECTIVE:
I. To determine if intra-vaginal curcumin administered once weekly for twenty weeks will be safe, acceptable and well-tolerated among women with and without HIV.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive curcumin intravaginally once a week (QW) for 20 weeks (excluding the time when they are on their menses). Patients then attend an optional focus group over 2-3 hours to discuss the acceptability of the medication.
ARM II: Patients receive placebo curcumin intravaginally QW for 20 weeks (excluding the time when they are on their menses). Patients then attend an optional focus group over 2-3 hours to discuss the acceptability of the medication.
After the completion of study treatment, patients are followed up to 6 months.
Lead OrganizationGrady Health System
Principal InvestigatorLisa C. Flowers
