WithdrawnEarly Phase 1

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

Stopped: no subject accrual

United States0Started 2015-06-22

Plain-language 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.

Who can participate

Age range21 Years

SexFEMALE

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Inclusion criteria

✓. The patient must be 21 or older and able to give informed consent.
✓. Patient must have histologically confirmed squamous CIN3.
✓. There must be an adequate colposcopy.
✓. Patient must have no abnormal cells in their endocervical curettage (ECC).
✓. There must be no suspicion of invasion.

Exclusion criteria

✕. Women who are pregnant or lactating.
✕. HIV+ status
✕. Adenocarcinoma in situ or any invasive cancer of the cervix.
✕. Gallstones or bile duct obstructions.
✕. Patients on anti-coagulant/anti-platelet therapies.
✕. Patients on immunosuppressive therapies.
✕. Patients may not receive any other investigational treatments while participating in this study.
✕. 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.

What they're measuring

Determine the safety and feasibility using curcumin in patients with CIN3 where toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Timeframe: 4 months

Trial details

NCT IDNCT02554344

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07-11

View on ClinicalTrials.gov More Cervical Intraepithelial Neoplasia trials