Clinical trial NCT02554344: Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
Official title: Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cervical Intraepithelial Neoplasia
Keywords: CIN3
Squamous CIN3
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 14
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Regression Rate
timeFrame: 4 months
measure: Overall Response
timeFrame: 4 months
measure: Pathologic Response
timeFrame: 4 months
measure: Rate of patients in which p65, phosphorylated p65, and acetylated p65 play a role in the persistence of CIN.
timeFrame: 4 months
measure: Evaluation of patients with CIN3 for the presence of high-risk HPV.
timeFrame: 4 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Charles A. Sammons Cancer Center
state: Texas
Study officials:
affiliation: Baylor Research Institute/Texas Oncology
name: Carolyn Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References: