Study on Using Topical Curcumin for HPV-Related Cervical Conditions

Sponsor: Lisa Flowers

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04266275

Provider View

This clinical trial is exploring whether curcumin, a natural compound found in turmeric, can help reduce HPV infections in women with mild or recently treated precancerous cervical lesions. The study involves applying curcumin capsules vaginally once a week and checking for HPV clearance after six months.

Patient Parameters

Program Overview

The study aims to find out if curcumin, a substance from turmeric, can help reduce HPV infections in women with mild precancerous cervical lesions or those who have recently been treated for more severe lesions. About 200 women will participate, using curcumin capsules or a placebo once a week. After six months, they will have a Pap smear and HPV test to see if the curcumin helps clear the virus. If HPV is still present or the Pap smear is abnormal, further examination will be done to check the cervical tissue.

Description

Cervical cancer is a common cancer worldwide, often caused by persistent HPV infection. Women with HIV are at higher risk due to weakened immune systems. While HPV vaccines can prevent cervical cancer, they are not widely available everywhere. Therefore, finding affordable and non-invasive treatments for early cervical changes is important.

Curcumin, from turmeric, is known for its anti-inflammatory and infection-fighting properties. It may help reduce tumors and precancerous lesions. This study will test if curcumin can reduce HPV infections in women with mild or recently treated precancerous cervical lesions. Participants will use curcumin capsules or a placebo vaginally once a week. After six months, they will have a Pap smear and HPV test to check for virus clearance. If HPV is still present or the Pap smear is abnormal, further examination will be done to assess cervical tissue.

Eligibility Criteria

Inclusion Criteria

  • Women with or without HIV (without current AIDS-related illness)
  • Must have a cervix
  • Diagnosed with mild precancerous cervical lesions or recently treated for more severe lesions
  • If HIV-positive, must be on consistent antiretroviral therapy with a CD4 count over 200 and undetectable viral load for at least 3 months
  • Using reliable birth control methods
  • Willing to follow study requirements
  • Able to provide reliable contact information
  • No risk factors for severe cervical disease
  • For those with severe lesions, must have completed treatment within 6 weeks and have healed adequately

Exclusion Criteria

  • Untreated severe cervical lesions or invasive features
  • Not following antiretroviral therapy if HIV-positive
  • CD4 count 200 or lower and detectable viral load in the last 3 months (HIV-positive)
  • Pregnant or breastfeeding
  • Irregular menstrual cycles
  • Not using reliable birth control
  • Previous hysterectomy
  • Previous cervical cancer diagnosis
  • Unable to give informed consent
  • Medical conditions that interfere with the study
  • Active cervical infection or serious cervical disease needing surgery
  • Known bleeding disorders

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