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Polyphenol

Topical Curcumin for HPV Related Cervical Disease

Atlanta, GA
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
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I have a cervix.
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I do not have HIV or AIDS.
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I am a woman who had a LEEP procedure for HSIL and healed well within the last 6 weeks.
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I have a confirmed low-grade or recently treated high-grade lesion.
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I don't have risk factors for severe cervical disease based on my latest exams.
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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:
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I am HIV positive and not following my HIV treatment plan.
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I have had my uterus removed.
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I have a serious cervical condition that may require surgery.
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I have a bleeding disorder.
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My biopsy shows untreated high-grade lesions or cancer.
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I have been diagnosed with cervical cancer, whether treated or not.
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I am currently pregnant or breastfeeding.

Timeline

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

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.

Find a Location

Closest Location:Emory University· Atlanta, GA

Who is running the clinical trial?

Lisa FlowersLead Sponsor
3 Previous Clinical Trials
555 Total Patients Enrolled
Lisa Flowers, MDPrincipal InvestigatorEmory University
3 Previous Clinical Trials
1,749 Total Patients Enrolled

Media Library

Curcumin C3 Complex (Polyphenol) Clinical Trial Eligibility Overview. Trial Name: NCT04266275 — Phase 2
Cervical Cancer Research Study Groups: Curcumin Arm, Placebo Arm
Cervical Cancer Clinical Trial 2023: Curcumin C3 Complex Highlights & Side Effects. Trial Name: NCT04266275 — Phase 2
Curcumin C3 Complex (Polyphenol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04266275 — Phase 2
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