Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Withdrawn
- Sponsor
- Baylor Research Institute
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief 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.
Detailed 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A patient will be eligible for inclusion in this study if she meets all of the following criteria:
- •The patient must be 21 or older and able to give informed consent.
- •Patient must have histologically confirmed squamous CIN
- •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
- •A patient will be ineligible for inclusion in this study if she meets any of the following 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.
Arms & Interventions
All Patients
Fourteen subjects with histologically confirmed squamous CIN3 will be enrolled in a single arm study. All patients will receive 500 mg of curcumin administered orally, twice a day for 12 weeks upon enrollment on trial.
Intervention: Curcumin (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: 4 months
Events will be recorded from the time of informed consent signature through the 30 days following the last study treatment.
Secondary Outcomes
- Regression Rate(4 months)
- Pathologic Response(4 months)
- Rate of patients in which p65, phosphorylated p65, and acetylated p65 play a role in the persistence of CIN.(4 months)
- Overall Response(4 months)
- Evaluation of patients with CIN3 for the presence of high-risk HPV.(4 months)