Curcumin for the Treatment of Patients with Cervical Intraepithelial Neoplasia

This randomized phase II trial studies curcumin to determine if it can clear human papillomavirus (HPV) infection or mild abnormal cells of the cervix in the treatment of patients with cervical intraepithelial neoplasia. These abnormal cells of the cervix are considered precancerous cells. Both invasive cervical cancers and precancerous cells have been firmly associated with the presence of high-risk HPV deoxyribonucleic acid (DNA). Not all precancerous cells progress to cancer. Curcumin, an extract from turmeric, a popular culinary spice, has been used in traditional Indian medicine for its anti-inflammatory and anti-infectious properties. Curcumin may slow down, destroy or prevent the growth of precancerous or cancer cells.

Inclusion Criteria

• HIV-uninfected and infected women (without current acquired immunodeficiency syndrome [AIDS]-defining illness)
• Presence of a cervix
• Biopsy-proven low-grade squamous intraepithelial lesion (LSIL) disease or recently treated high-grade squamous intraepithelial lesion (HSIL) disease
• Adherence to combined anti-retrovirals (cART) if HIV infected
• On continuous antiretrovirals with a 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, loop electrosurgical excision procedure (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

PRIMARY OBJECTIVE:

I. To determine if intravaginal curcumin will have higher rates of HPV clearance at 6 months compared to placebo in human immunodeficiency virus (HIV)-uninfected and infected women.

SECONDARY OBJECTIVE:

I. To determine if intra-vaginal curcumin administered once weekly for twenty weeks will be safe, acceptable and well-tolerated among women with and without HIV.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive curcumin intravaginally once a week (QW) for 20 weeks (excluding the time when they are on their menses). Patients then attend an optional focus group over 2-3 hours to discuss the acceptability of the medication.

ARM II: Patients receive placebo curcumin intravaginally QW for 20 weeks (excluding the time when they are on their menses). Patients then attend an optional focus group over 2-3 hours to discuss the acceptability of the medication.

After the completion of study treatment, patients are followed up to 6 months.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Children's Healthcare of Atlanta - Egleston

Principal Investigator
Lisa Flowers

• Primary ID GRADY4943-20
• Secondary IDs NCI-2020-01951
• Clinicaltrials.gov ID NCT04266275