Topical Curcumin for Precancer Cervical Lesions

NCT02944578 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00079183
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Human Papillomavirus (HPV) Related Molecular Target HPV E6/E7 Messenger Ribonucleic Acid (mRNA) Expression Within HSIL Lesions of the Cervix

  Vaginal samples were 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.

  Baseline, Weeks 4, 8, 12, and 16

Secondary Outcomes (1)

• Curcumin Levels in Cervical Tissue

  Weeks 4, 8, 12, and 16

Other Outcomes (5)

• Explore the Association Between Curcumin and Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NF-κB)

  Baseline, Weeks 4, 8, 12, and 16

• Explore the Association Between Curcumin and p16INK4a

  Baseline, Weeks 4, 8, 12, and 16

• Explore the Association Between Curcumin and Rb

  Baseline, Weeks 4, 8, 12, and 16

Study Arms (2)

Curcumin Arm

EXPERIMENTAL

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

Drug: Curcumin

Placebo Arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Curcumin DRUG

Curcumin (Curcumin C3 Complex®, prepared by Sabinsa Corporation), a constituent of the spice turmeric, is considered to be a low-toxicity, dietary-derived agent with chemopreventive and therapeutic benefits. Study participants will be instructed to insert four 500 mg (2000 mg total) curcumin capsules once a week (excluding days when they are on their menses). Participants will insert the capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs. Cervical cytology, colposcopies and biopsies will be performed at the Baseline, Week 4, 8, 12 and 16 visits to collect samples to analyze for the study outcomes.

Also known as: Curcumin C3 Complex

Curcumin Arm

Placebo DRUG

Study participants randomized to the placebo arm will insert four 500 mg (2000 mg total) of the placebo (gelatin) capsules once a week (excluding days when they are on their menses). Participants will insert the capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs. Cervical cytology, colposcopies and biopsies will be performed at the Baseline, Week 4, 8, 12 and 16 visits to collect samples to analyze for the study outcomes.

Placebo Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Lactating and pregnant women
• Patient with irregular cycles (more than once a month).
• Previous hysterectomy and/or prior treatment for cervical precancer condition

Sponsors & Collaborators

• Lisa Flowers: lead

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Grady Hospital - Ponce De Leon Clinic

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Neoplasms; Communicable Diseases

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Dr. Lisa Flowers
• Organization: Emory University

flowe2@emory.edu

404-251-8931

Study Officials

• Lisa Flowers, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Study Start: November 20, 2017
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: October 29, 2024
• Results First Posted: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)