Clinical trial NCT02944578: Topical Curcumin for Precancer Cervical Lesions
Official title: Biomolecular Effects of Topical Curcumin in HSIL Cervical Neoplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neoplasms
Keywords: Cancer
HIV
Oncology
Infectious Diseases
HPV
Preventive Medicine
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 7
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 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.

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 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.

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

Primary outcomes:
measure: Number of Participants With Human Papillomavirus (HPV) Related Molecular Target HPV E6/E7 Messenger Ribonucleic Acid (mRNA) Expression Within HSIL Lesions of the Cervix
timeFrame: Baseline, Weeks 4, 8, 12, and 16
Secondary outcomes:
measure: Curcumin Levels in Cervical Tissue
timeFrame: Weeks 4, 8, 12, and 16
Other outcomes:
measure: Explore the Association Between Curcumin and Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NF-κB)
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Explore the Association Between Curcumin and p16INK4a
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Explore the Association Between Curcumin and Rb
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Explore the Association Between Curcumin and p53
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Explore the Association Between Curcumin and Vascular Endothelial Growth Factor (VEGF)
timeFrame: Baseline, Weeks 4, 8, 12, and 16
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Grady Hospital - Ponce De Leon Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Lisa Flowers, MD
role: PRINCIPAL_INVESTIGATOR
References: