This randomized phase II trial studies how well curcumin works in treating human immunodeficiency virus (HIV) infected and uninfected women with high grade cervical squamous intraepithelial neoplasia. Natural or herbal treatments, such as curcumin, may help slow down destroy, or prevent the growth of precancerous cells.
Additional locations may be listed on ClinicalTrials.gov for NCT02944578.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Determine the association between intravaginal curcumin on known human papilloma virus (HPV)-related molecular target HPV E6/E7 messenger ribonucleic acid (mRNA) expression within high grade squamous intraepithelial lesion (HSIL) lesions of the cervix in HIV uninfected and infected women.
SECONDARY OBJECTIVE:
I. To quantify levels of curcumin in the cervix of women in the curcumin treatment arm.
EXPLORATORY OBJECTIVE:
I. To determine the association between curcumin and other known biomarkers of cervical disease and its effect on the vaginal microbiome.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive 4 capsules of curcumin inserted intra-vaginally daily at bedtime for 12 weeks (excluding the time when they are menstruating). Patients undergo a pelvic exam with vaginal sampling and colposcopy with targeted cervical biopsies at weeks 4, 8 and 12. Patients undergo standard of care loop electrosurgical excision procedure (LEEP) at week 16.
ARM II: Patients receive 4 capsules of placebo inserted intra-vaginally daily at bedtime for 12 weeks (excluding the time when they are menstruating). Patients undergo a pelvic exam with vaginal sampling and colposcopy with targeted cervical biopsies at weeks 4, 8 and 12. Patients undergo standard of care LEEP at week 16.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorLisa C. Flowers
