Topical Curcumin for HPV Related Cervical Disease

Not yet recruiting at 2 trial locations

Overseen By Lisa Flowers, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Lisa Flowers

Must be taking: Antiretrovirals, Birth control

Disqualifiers: Pregnancy, Irregular cycles, Hysterectomy, Cervical cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether curcumin, a natural compound in turmeric, can help clear HPV infections in women with certain precancerous cervical conditions. Participants will use either curcumin (specifically, Curcumin C3 Complex) or a placebo (a substance with no active ingredient) inserted vaginally once a week for 20 weeks. Eligible women should have mild precancerous cervical lesions or have recently been treated for more severe ones, without current signs of more severe disease. The goal is to determine if curcumin aids in clearing the HPV infection during check-ups in six months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are HIV-positive, you must continue your anti-retroviral therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that curcumin cream is generally safe. In past studies, when used inside the vagina, most people experienced only mild to moderate side effects, such as irritation and itching. Importantly, no serious side effects were reported.

These findings come from earlier research on using curcumin for cervical issues similar to those under current study. This information suggests that the treatment should be safe for prospective trial participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for HPV-related cervical disease, which often include surgical procedures like cryotherapy or LEEP (Loop Electrosurgical Excision Procedure), the study treatment uses curcumin, a natural compound found in turmeric. Researchers are excited about this because curcumin has anti-inflammatory and anti-viral properties that could help treat the disease without invasive surgery. Additionally, the unique intravaginal delivery of curcumin allows it to directly target the affected area, potentially offering a more localized and less systemic treatment option. This approach may provide a gentler alternative with fewer side effects compared to traditional methods.

What evidence suggests that curcumin might be an effective treatment for HPV-related cervical disease?

Research has shown that curcumin, a natural compound, may assist with cervical issues related to HPV. Lab and animal studies suggest that curcumin can combat cervical cancer and precancerous conditions. Early human trials found that using curcumin vaginally is safe and well-tolerated. In this trial, participants in the Curcumin Arm will use intravaginal curcumin, while those in the Placebo Arm will receive a placebo treatment. These findings offer hope that curcumin might help clear HPV infections in women with mild or recently treated severe precancerous lesions. Although more research is needed to confirm these findings, the initial results are promising. ^{1 2 3 4 5}

Who Is on the Research Team?

Lisa Flowers, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for women with low-grade cervical precancerous lesions or those treated for high-grade lesions, at risk of persistent HPV. Participants must be on reliable birth control, not pregnant or lactating, without a history of cervical cancer or hysterectomy. HIV-positive women must have controlled infection.

Inclusion Criteria

I have a cervix.

I do not have HIV or AIDS.

Reliable follow-up and contact information

Exclusion Criteria

I am HIV positive and not following my HIV treatment plan.

I have had my uterus removed.

CD4 count =<200 cells/ml and detectable viral load within the last 3 months (only for HIV-positive participants)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 2000 mg of intravaginal curcumin or placebo once a week for 20 weeks

20 weeks

Weekly self-administration

Follow-up

Participants undergo a Pap smear and HPV test to determine HPV clearance

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Curcumin C3 Complex
• Placebo

Trial Overview The study tests if vaginal curcumin capsules can clear HPV in affected women compared to a placebo. About 200 participants will insert either curcumin (2000 mg) or placebo weekly and undergo follow-up Pap smears and HPV tests after six months.

How Is the Trial Designed?

Group I: Curcumin Arm Experimental Treatment 1 Intervention

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

Group II: Placebo Arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Lisa Flowers

Lead Sponsor

Trials

4

Recruited

760+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04266275

Topical Curcumin for HPV Related Cervical Disease The purpose of this study is to see if curcumin can suppress HPV infection in women with low-grade squamous intraepithelial lesions (LSIL) disease.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5459318/

Phase I dose-escalation trial of intravaginal curcumin in ... This is a Phase I trial demonstrating safety and tolerability of intravaginal curcumin for future use in women with cervical neoplasia.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0753332223003785

Basic research on curcumin in cervical cancer In recent years, numerous in vitro and in vivo studies have found that curcumin can have significant efficacy in anti-cervical cancer treatment by promoting ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02944578

Topical Curcumin for Precancer Cervical Lesions The purpose of this study is to see if curcumin can reverse a cervical precancerous state by looking at people who have the condition and intervening with a ...

5. withpower.com withpower.com/trial/phase-3-uterine-cervical-neoplasms-11-2021-a1f6f

Topical Curcumin for HPV Related Cervical Disease This trial is testing if curcumin capsules can help clear HPV infections in women with mild or recently treated severe precancerous cervical lesions.