Dallas, Texas 75246


Purpose:

The purpose of this study is to determine the safety, feasibility, and regression rate of using curcumin in patients with Cervical Intraepithelial neoplasias (CIN3). The secondary objectives of this study is to evaluate patients with CIN3 for the presence of high-risk Human papillomavirus (HPV) and to perform an inflammatory panel on dysplasia biopsies from patients with CIN3 to determine which factors play a role in persistence of CIN3.


Study summary:

Fourteen women with a biopsy-confirmed CIN3 diagnosis will be enrolled. The participants will receive 500mg of curcumin orally twice daily for 12 weeks. Colposcopies will be performed at the participants' baseline, 6 week, and 12 week visits. Two biopsies will be performed at the baseline and 12 week visit, and if there is suspicion for cancer formation or invasion, at the 6-week visit. One sample will be used for histologic examination, while the other sample will be used for p65 assays. Based on the biopsy, if cancer is present, then the patient will be referred to gynecologic oncology for further care and the trial will be terminated. At the end of the 12 week period, if CIN3 persists, Loop electrosurgical excision procedure (LEEP) or Cold knife conisation (CKC) will be performed to remove the dysplastic cells as this is considered standard of care.


Criteria:

Inclusion Criteria: A patient will be eligible for inclusion in this study if she meets all of the following criteria: 1. The patient must be 21 or older and able to give informed consent. 2. Patient must have histologically confirmed squamous CIN3. 3. There must be an adequate colposcopy. 4. Patient must have no abnormal cells in their endocervical curettage (ECC). 5. There must be no suspicion of invasion. Exclusion Criteria: A patient will be ineligible for inclusion in this study if she meets any of the following criteria: 1. Women who are pregnant or lactating. 2. HIV+ status 3. Adenocarcinoma in situ or any invasive cancer of the cervix. 4. Gallstones or bile duct obstructions. 5. Patients on anti-coagulant/anti-platelet therapies. 6. Patients on immunosuppressive therapies. 7. Patients may not receive any other investigational treatments while participating in this study. 8. Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.


NCT ID:

NCT02554344


Primary Contact:

Principal Investigator
Carolyn Matthews, MD
Baylor Research Institute/Texas Oncology

Grace Townsend
Phone: 214-818-8382
Email: grace.townsend@baylorhealth.edu


Backup Contact:

Email: gabriele@BaylorHealth.edu
Gaby Ethington
Phone: 214-818-8326


Location Contact:

Dallas, Texas 75246
United States

Grace Townsend
Phone: 214-818-8382
Email: grace.townsend@baylorhealth.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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