Topical Curcumin for HPV Related Cervical Disease

NCT04266275 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00000758IRB00117251
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Neoplasm Cervix

Keywords

Cancer; HIV; Oncology; Infectious disease; HPV; Preventive medicine

Outcome Measures

Primary Outcomes (1)

• HPV Clearance

  HPV clearance, assessed as the number of participants with undetectable high-risk HPV mRNA levels in the standard monolayer Pap test (ThinPrep), at 6 months will be compared between the curcumin and placebo study arms.

  Month 6

Secondary Outcomes (1)

• Disease Recurrence

  Month 6

Other Outcomes (1)

• Participant Discontinuation

  Month 6

Study Arms (2)

Curcumin Arm

EXPERIMENTAL

Participants in this arm will use 2000 mg of intravaginal curcumin once a week for 20 weeks

Drug: Curcumin C3 Complex

Placebo Arm

PLACEBO COMPARATOR

Participants in this arm will use 2000 mg of intravaginal placebo once a week for 20 weeks

Drug: Placebo

Interventions

Curcumin C3 Complex DRUG

Curcumin (Curcumin C3 Complex prepared by Sabinsa Corporation), a constituent of the spice turmeric, is considered to be a low-toxicity, dietary-derived agent with chemopreventative and therapeutic benefits. Study participants will be instructed to insert four 500 mg (2000 mg total) curcumin capsules once a week (excluding days when they are on their menses) for 20 weeks. Participants will insert capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs. Cervical cytology and HPV testing will be performed at baseline and 6 months after the baseline visit. If cervical cytology or HPV testing is abnormal at 6 months, a colposcopy with biopsies will be performed. All samples will be used to analyze for the study outcomes.

Curcumin Arm

Placebo DRUG

Study participants randomized to the placebo arm will insert four 500 mg (2000 mg total) of the placebo (gelatin) capsules once a week (excluding days when they are on their menses) for 20 weeks. Participants will insert the capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs. Cervical cytology and HPV testing will be performed at baseline and 6 months after the baseline visit. If cervical cytology or HPV testing is abnormal at 6 months, a colposcopy with biopsies will be performed. All samples will be used to analyze for the study outcomes.

Placebo Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lisa Flowers: lead

Study Sites (3)

Emory University

Atlanta, Georgia, 30303, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Grady Hospital - Ponce De Leon Clinic

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms; Communicable Diseases

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Flowers, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Flowers, MD

CONTACT

404-251-8931; lflowe2@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: February 12, 2020
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available for sharing beginning 3 months and ending 5 years following article publication.
• Access Criteria: Data will be available for sharing with researchers providing a methodologically sound proposal, in order to achieve aims in the approved proposal. Proposals should be directed to lflowe2@emory.edu. To gain access, data requestor will need to sign a data access agreement.

Locations

US (3)