Topical Curcumin for HPV Related Cervical Disease

ConditionNeoplasm Cervix

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age21+

SponsorLisa Flowers

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Curcumin ArmExperimental treatment 1 intervention

Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Month 6

Secondary outcomes

Disease Recurrence

Disease recurrence will be assessed either cytologic or histologic abnormality at 6 months. Rates of disease recurrence will be compared between study arms in HIV-uninfected and infected women.

Time frame

Month 6

Other outcomes

Participant Discontinuation

The treatment will be considered tolerable if 25% or fewer of participants discontinue the study early.

Time frame

Month 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lisa Flowers

Lead sponsor

Emory University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: