What is the mechanism of action of this treatment?

Common treatments for cervical cancer include surgery, radiation therapy, chemotherapy, and targeted therapies. Surgery involves the physical removal of cancerous tissues, which is crucial for localized tumors. Radiation therapy uses high-energy rays to kill cancer cells by damaging their DNA, making it effective for both localized and some advanced cancers. Chemotherapy employs drugs to target rapidly dividing cells, including cancer cells, disrupting their growth and division. Targeted therapies, such as those inhibiting specific proteins involved in cancer cell proliferation, offer a more precise approach. The antiviral and anti-inflammatory properties of curcumin, currently under study, may provide additional benefits by reducing HPV infection and inflammation, potentially lowering the risk of cancer progression. These mechanisms are vital for cervical cancer patients as they offer multiple avenues to control and eliminate cancer cells, improving survival rates and quality of life.

What side effects are associated with this type of intervention?

Common treatments for cervical cancer, such as topical 5-fluorouracil, imiquimod, and sinecatechins, can have various side effects. Topical 5-fluorouracil may cause local irritation, burning, and inflammation. Imiquimod can lead to localized skin reactions, including redness, swelling, and ulceration. Sinecatechins, derived from green tea extract, may cause itching, burning, and erythema at the application site. Broader treatments like radiation therapy can result in fatigue, skin changes, and gastrointestinal symptoms, while chemotherapy often leads to nausea, vomiting, hair loss, and increased risk of infection.

What prior FDA approvals exist?

FDA-approved treatments for cervical cancer include various chemotherapeutic agents, targeted therapies, and immunotherapies. Notably, the FDA has approved the use of pembrolizumab, an immune checkpoint inhibitor, for advanced cervical cancer. Pembrolizumab works by enhancing the body's immune response against cancer cells, which aligns with the immune-modulating properties of curcumin. Additionally, bevacizumab, an anti-angiogenic agent, has been approved for use in combination with chemotherapy for persistent, recurrent, or metastatic cervical cancer. While these treatments do not have direct antiviral properties, they represent the current landscape of advanced cervical cancer therapies.

What other types of research exist?

Promising novel alternatives to curcumin for cervical cancer patients include: 1) Sinecatechins (green tea extract) which has shown efficacy in treating HPV-related lesions, 2) Imiquimod, an immune-response modifier that has demonstrated effectiveness in clearing HPV-related lesions, and 3) Indole-3-carbinol, which has been studied for its potential in treating HPV-induced neoplasia. These alternatives have shown antiviral and anti-inflammatory properties in clinical studies.

← Back to Search

Polyphenol

Topical Curcumin for HPV Related Cervical Disease

Phase 2

Waitlist Available

Led By Lisa Flowers, MD

Research Sponsored by Lisa Flowers

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of a cervix

HIV-uninfected and infected women (without current AIDS-defining illness)

Must not have

Not adherent to anti-retroviral therapy (cART) (HIV infected participants)

Previous hysterectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Summary

This trial is testing if curcumin capsules can help clear HPV infections in women with mild or recently treated severe precancerous cervical lesions. The study includes both HIV-infected and uninfected women. Curcumin, a substance from turmeric, might reduce inflammation and infection, helping to prevent cervical cancer. Curcumin and curcumin containing polyherbal preparations have demonstrated anti-microbial and anti-viral properties in pre-clinical studies.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include local irritation or discomfort from the vaginal insertion of curcumin capsules.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a cervix.

Select...

I do not have HIV or AIDS.

Select...

I am a woman who had a LEEP procedure for HSIL and healed well within the last 6 weeks.

Select...

I have a confirmed low-grade or recently treated high-grade lesion.

Select...

I don't have risk factors for severe cervical disease based on my latest exams.

Select...

I am HIV-positive, on antiretrovirals, with a CD4 count over 200 and an undetectable viral load for 3+ months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have had my uterus removed.

Select...

I have a serious cervical condition that may require surgery.

Select...

I have a bleeding disorder.

Select...

My biopsy shows untreated high-grade lesions or cancer.

Select...

I have been diagnosed with cervical cancer, whether treated or not.

Select...

I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HPV Clearance

Secondary study objectives

Disease Recurrence

Other study objectives

Participant Discontinuation

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Curcumin ArmExperimental Treatment1 Intervention

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

Group II: Placebo ArmPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Curcumin C3 Complex

2008

Completed Phase 2

~40

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cervical cancer include surgery, radiation therapy, chemotherapy, and targeted therapies. Surgery involves the physical removal of cancerous tissues, which is crucial for localized tumors. Radiation therapy uses high-energy rays to kill cancer cells by damaging their DNA, making it effective for both localized and some advanced cancers. Chemotherapy employs drugs to target rapidly dividing cells, including cancer cells, disrupting their growth and division. Targeted therapies, such as those inhibiting specific proteins involved in cancer cell proliferation, offer a more precise approach. The antiviral and anti-inflammatory properties of curcumin, currently under study, may provide additional benefits by reducing HPV infection and inflammation, potentially lowering the risk of cancer progression. These mechanisms are vital for cervical cancer patients as they offer multiple avenues to control and eliminate cancer cells, improving survival rates and quality of life.

Natural Bioactives: Back to the Future in the Fight against Human Papillomavirus? A Narrative Review.Proteomics-based approach to elucidate the mechanism of antitumor effect of curcumin in cervical cancer.