Clinical Trials /

Topical Curcumin for Precancer Cervical Lesions

NCT02944578

Description:

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 study drug or placebo (an inactive drug), prior to planned therapeutic loop electrosurgical excision procedure (LEEP) which is a treatment procedure for removing cervical cancer. 40 women with high grade squamous intraepithelial lesion (HSIL) of the cervix will be enrolled to either insert 2000 mg capsule of curcumin or a placebo in their vagina daily for 12 weeks. After a 4 week long washout period the participants will then undergo removal of the precancerous cells as recommended standard of care. Participants will have regular monthly visits for the duration of the study.

Related Conditions:
  • High Grade Cervical Intraepithelial Neoplasia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Topical Curcumin for Precancer Cervical Lesions
  • Official Title: Biomolecular Effects of Topical Curcumin in HSIL Cervical Neoplasia

Clinical Trial IDs

  • ORG STUDY ID: IRB00079183
  • NCT ID: NCT02944578

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
CurcuminCurcumin C3 ComplexCurcumin Arm
PlaceboPlacebo Arm

Purpose

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 study drug or placebo (an inactive drug), prior to planned therapeutic loop electrosurgical excision procedure (LEEP) which is a treatment procedure for removing cervical cancer. 40 women with high grade squamous intraepithelial lesion (HSIL) of the cervix will be enrolled to either insert 2000 mg capsule of curcumin or a placebo in their vagina daily for 12 weeks. After a 4 week long washout period the participants will then undergo removal of the precancerous cells as recommended standard of care. Participants will have regular monthly visits for the duration of the study.

Detailed Description

      Cervical cancer is the third most common cancer worldwide. The causative agent responsible
      for cervical cancer is the persistent infection with oncogenic Human Papillomavirus (HPV).
      Rates of cervical cancer and HPV infection are increased in HIV-infected women due to
      immunosuppression and cervical cancer is an AIDS-defining diagnosis. Despite the promise of
      HPV vaccine in the prevention of cervical cancer, the widespread availability of this vaccine
      is limited due to cost and accessibility. Therefore, prevention strategies to reduce cervical
      cancer after HPV exposure entail treatment at the most severe premalignant state (high grade
      squamous intraepithelial lesion or HSIL). As this procedure is expensive and not widely
      available in resource-limited areas there is a need for an inexpensive, non-invasive
      alternative method to treat these premalignant cervical lesions.

      Curcumin, an extract from turmeric, a popular culinary spice, has been used in traditional
      Indian medicine for its anti-inflammatory and anti-infectious properties. Recent studies have
      shown the potential effect of curcumin to reduce tumors and precancerous lesions in animal
      and human cancer cells. It is postulated that curcumin achieves its effect on cancer cells by
      modulating different cellular pathways as well as altering HPV effect on tissue cells.

      This study will explore the effect of curcumin as a potential medical treatment in
      HIV-infected women with HSIL lesions of the cervix. 40 women with high grade squamous
      intraepithelial lesion (HSIL) of the cervix will be enrolled to either insert 2000 mg capsule
      of curcumin or a placebo in their vagina daily for 12 weeks. After a 4 week long washout
      period the participants will then undergo removal of the precancerous cells as recommended
      standard of care. Participants will have regular monthly visits for the duration of the
      study.
    

Trial Arms

NameTypeDescriptionInterventions
Curcumin ArmExperimentalParticipants in this arm will use 2000 mg of intravaginal curcumin daily for 12 weeks.
  • Curcumin
Placebo ArmPlacebo ComparatorParticipants in this arm will use 2000 mg of a placebo daily for 12 weeks.
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  HIV positive women and HIV negative women

          -  HSIL cytology with no invasive features identified on colposcopy or the baseline
             biopsy

          -  Compliant on combined antiretrovirals (cART)

          -  On continuous antiretrovirals with cluster of differentiation 4 (CD4) count >200
             cells/ml with sustained undetectable viral load for at least 3 months

          -  Patient on reliable birth control. Adequate birth control includes: Combined oral
             contraceptive pill (OCP), Long Lasting Reversible Contraceptive (LARCP), BiLateral
             Tubal Ligation (BLT) and DepoProvera Shot/Birth control shot.

          -  Patient willing to conform to the study requirements

          -  No risk factors for microinvasive disease (no colposcopic features of microinvasion,
             adequate colposcopy and negative endocervical curettage)

        Exclusion Criteria:

          -  Lactating and pregnant women

          -  Patient with irregular cycles (more than once a month).

          -  Previous hysterectomy and/or prior treatment for cervical precancer condition
      
Maximum Eligible Age:N/A
Minimum Eligible Age:21 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change in human papillomavirus (HPV) related molecular target HPV E6/E7 messenger ribonucleic acid (mRNA) expression within HSIL lesions of the cervix
Time Frame:Baseline, Weeks 4, 8, 12, and 16
Safety Issue:
Description:Vaginal sampling and colposcopy with targeted cervical biopsies will be performed at each study visit. These samples will be used to determine the association between intravaginal curcumin on known HPV-related molecular target HPV E6/E7 mRNA expression within high grade squamous intraepithelial (HSIL) lesions of the cervix in HIV- infected women. The APTIMA® HPV Assay that will be utilized detects full-length HPV E6/E7 mRNA for HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 and correlates very well with integrated HPV, which in turn correlates with full-length HPV E6/E7 protein levels.

Secondary Outcome Measures

Measure:Quantify curcumin levels in cervical tissue
Time Frame:Baseline, Weeks 4, 8, 12, and 16
Safety Issue:
Description:Vaginal sampling and colposcopy with targeted cervical biopsies will be performed at each study visit. These samples will be examined to establish the level of curcumin penetration in cervical tissue, as well as the cumulative effect of daily curcumin over time.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Emory University

Trial Keywords

  • Cancer
  • HIV
  • Oncology
  • Infectious Diseases
  • HPV
  • Preventive Medicine

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