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Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:
Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02554344
Study type Interventional
Source Baylor Research Institute
Contact Grace Townsend
Phone 214-818-8382
Email grace.townsend@baylorhealth.edu
Status Recruiting
Phase Phase 0
Start date March 2016
Completion date January 2017
View Details
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