Topical Curcumin for HPV Related Cervical Disease

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to see if curcumin can suppress HPV infection in women with low-grade squamous intraepithelial lesions (LSIL) disease or treated high-grade squamous intraepithelial lesions (HSIL) disease. This study plans to explore the effect of curcumin as a potential medical treatment in HIV-uninfected and infected women with mild precancerous lesions of the cervix or recently treated high-grade precancerous lesions at risk for persistent HPV infection. About 200 women with low-grade precancerous lesions of the cervix or recently treated high-grade precancerous lesions will be enrolled to either insert 2000 mg of curcumin capsules in their vagina once a week or placebo after undergoing colposcopy or loop electrosurgical excision procedure (LEEP). They will have a repeat visit in 6 months where they will undergo a Pap smear and HPV test to determine if there are higher rates of HPV clearance after curcumin administration. If HPV is present or the Pap smear is abnormal, patients will then undergo colposcopic examination to evaluate cervical histology.

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

Details

• Lead Sponsor: Lisa Flowers
• Treatments: Curcumin

Criteria

Inclusion Criteria:

• HIV-uninfected and infected women (without current AIDS-defining illness)

• Presence of a cervix

• Biopsy-proven LSIL disease or recently treated HSIL disease

• Adherence to combined anti-retrovirals (cART) if HIV infected

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

• On reliable birth control: combined oral contraceptive pills (OCP), long-acting reversible contraception (LARC), bilateral tubal ligation (BTL) or Depo-Provera (birth control shot)

• Willing to conform to the study requirements

• Reliable follow-up and contact information

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

• For women with HSIL only, LEEP completed within 6 weeks preceding initial encounter with study staff and adequate wound healing

Exclusion Criteria:

• Untreated HSIL or invasive features on colposcopy and the biopsy specimen

• Not adherent to anti-retroviral therapy (cART) (HIV infected participants)

• CD4 count =<200 cells/ml and detectable viral load within the last 3 months (only for HIV-positive participants)

• Lactating and pregnant people

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

• Not on reliable birth control.

• Previous hysterectomy

• Prior diagnosis of cervical cancer, treated or untreated

• Inability to provide informed consent

• Medical condition that interferes with the conduct of the study in the investigator's opinion

• Evidence of active cervical infection or serious cervical disease necessitating surgery

• Known bleeding diathesis