Suspended

Biomolecular Effects of Topical Curcumin in HSIL Cervical Neoplasia

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What is being tested

Curcumin

+ Placebo

Drug
Who is being recruted

Communicable Diseases+3

+ Infections

+ Neoplasms

Over 21 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: November 2017
See protocol details

Summary

Principal SponsorLisa Flowers
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 20, 2017

Actual date on which the first participant was enrolled.

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 once a week 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.

Official TitleBiomolecular Effects of Topical Curcumin in HSIL Cervical Neoplasia
NCT02944578
Principal SponsorLisa Flowers
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Communicable DiseasesInfectionsNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Criteria

7 inclusion criteria required to participate
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

Show More Criteria

3 exclusion criteria prevent from participating
Lactating and pregnant women

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

Previous hysterectomy and/or prior treatment for cervical precancer condition

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants in this arm will use 2000 mg of intravaginal curcumin once a week for 12 weeks.

Group II

Placebo
Participants in this arm will use 2000 mg of a placebo once a week for 12 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Grady Memorial Hospital

Atlanta, United StatesOpen Grady Memorial Hospital in Google Maps
Suspended

Grady Hospital - Ponce De Leon Clinic

Atlanta, United States
Suspended2 Study Centers