Topical Curcumin for Precancer Cervical Lesions

• Status: Suspended
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to see if curcumin can reverse a cervical precancerous state by looking at people who have the condition and intervening with a study drug or placebo (an inactive drug), prior to planned therapeutic loop electrosurgical excision procedure (LEEP) which is a treatment procedure for removing cervical cancer. 40 women with high grade squamous intraepithelial lesion (HSIL) of the cervix will be enrolled to either insert 2000 mg capsule of curcumin or a placebo in their vagina once a week for 12 weeks. After a 4 week long washout period the participants will then undergo removal of the precancerous cells as recommended standard of care. Participants will have regular monthly visits for the duration of the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Curcumin

Criteria

Inclusion Criteria:

• HIV positive women and HIV negative women

• HSIL cytology with no invasive features identified on colposcopy or the baseline biopsy

• Compliant on combined antiretrovirals (cART)

• On continuous antiretrovirals with cluster of differentiation 4 (CD4) count >200 cells/ml with sustained undetectable viral load for at least 3 months

• Patient on reliable birth control. Adequate birth control includes: Combined oral contraceptive pill (OCP), Long Lasting Reversible Contraceptive (LARCP), BiLateral Tubal Ligation (BLT) and DepoProvera Shot/Birth control shot.

• Patient willing to conform to the study requirements

• No risk factors for microinvasive disease (no colposcopic features of microinvasion, adequate colposcopy and negative endocervical curettage)

Exclusion Criteria:

• Lactating and pregnant women

• Patient with irregular cycles (more than once a month).

• Previous hysterectomy and/or prior treatment for cervical precancer condition