Topical Curcumin for Precancer Cervical Lesions

Cervical cancer is the third most common cancer worldwide. The causative agent responsible
for cervical cancer is the persistent infection with oncogenic Human Papillomavirus (HPV).
Rates of cervical cancer and HPV infection are increased in HIV-infected women due to
immunosuppression and cervical cancer is an AIDS-defining diagnosis. Despite the promise of
HPV vaccine in the prevention of cervical cancer, the widespread availability of this vaccine
is limited due to cost and accessibility. Therefore, prevention strategies to reduce cervical
cancer after HPV exposure entail treatment at the most severe premalignant state (high grade
squamous intraepithelial lesion or HSIL). As this procedure is expensive and not widely
available in resource-limited areas there is a need for an inexpensive, non-invasive
alternative method to treat these premalignant cervical lesions.

Curcumin, an extract from turmeric, a popular culinary spice, has been used in traditional
Indian medicine for its anti-inflammatory and anti-infectious properties. Recent studies have
shown the potential effect of curcumin to reduce tumors and precancerous lesions in animal
and human cancer cells. It is postulated that curcumin achieves its effect on cancer cells by
modulating different cellular pathways as well as altering HPV effect on tissue cells.

This study will explore the effect of curcumin as a potential medical treatment in
HIV-infected women with HSIL lesions of the cervix. 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 daily 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.

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