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Curcumin in Treating HIV Infected and Uninfected Women with High Grade Cervical Squamous Intraepithelial Neoplasia


Active: Yes
Cancer Type: Cervical Cancer NCT ID: NCT02944578
Trial Phases: Phase II Protocol IDs: EU2971-15 (primary)
NCI-2016-01405
IRB00079183
Eligibility: 21 Years and older, Female Study Type: Treatment
Study Sponsor: Emory University Hospital/Winship Cancer Institute
NCI Full Details: http://clinicaltrials.gov/show/NCT02944578

Summary

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.

Objectives

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.

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org



Georgia Cancer Center for Excellence at Grady
80 Jesse Hill Jr. Drive, SE
Atlanta, GA 30303
404-489-9000
www.gradyhealth.org



Grady Memorial Hospital
80 Jesse Hill Jr. Drive, SE
Atlanta, GA 30303
www.gradyhealth.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.