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Official Title

An Investigation in the Use of Curcumin Topical Herbal Agent for the Treatment of Cervical Intraepithelial Neoplasia

Phase
Phase 2
Sponsor
Lisa Flowers
Enrollment
200
Timeline
Mar 2026 → Oct 2027
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1HIV-uninfected and infected women (without current AIDS-defining illness)
  • 2Presence of a cervix
  • 3Biopsy-proven LSIL disease or recently treated HSIL disease
  • 4Adherence to combined anti-retrovirals (cART) if HIV infected
  • 5On 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)
  • 6On reliable birth control: combined oral contraceptive pills (OCP), long-acting reversible contraception (LARC), bilateral tubal ligation (BTL) or Depo-Provera (birth control shot)
  • 7Willing to conform to the study requirements
  • 8Reliable follow-up and contact information
  • 9No risk factors for HSIL or microinvasive disease (no colposcopic features of microinvasion, adequate colposcopy and negative endocervical curettage)
  • 10For women with HSIL only, LEEP completed within 6 weeks preceding initial encounter with study staff and adequate wound healing

Exclusion Criteria

  • 1Untreated HSIL or invasive features on colposcopy and the biopsy specimen
  • 2Not adherent to anti-retroviral therapy (cART) (HIV infected participants)
  • 3CD4 count =\<200 cells/ml and detectable viral load within the last 3 months (only for HIV-positive participants)
  • 4Lactating and pregnant people
  • 5Patient with irregular cycles (more than once a month)
  • 6Not on reliable birth control.
  • 7Previous hysterectomy
  • 8Prior diagnosis of cervical cancer, treated or untreated
  • 9Inability to provide informed consent
  • 10Medical condition that interferes with the conduct of the study in the investigator's opinion
  • 11Evidence of active cervical infection or serious cervical disease necessitating surgery
  • 12Known bleeding diathesis

Locations

3 sites participating in this study

Emory University

Atlanta, Georgia 30303

Recruiting

Grady Memorial Hospital

Atlanta, Georgia 30303

Recruiting

Grady Hospital - Ponce De Leon Clinic

Atlanta, Georgia 30308

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →