Brief Title
Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
Official Title
Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
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 Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
Regression Rate
Condition
Cervical Intraepithelial Neoplasia
Intervention
Curcumin
Study Arms / Comparison Groups
All Patients
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
14
Start Date
March 2016
Completion Date
January 2017
Primary Completion Date
January 2017
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.
Gender
Female
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Carolyn Matthews, MD, 214-818-8382, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02554344
Organization ID
015-074
Responsible Party
Sponsor
Study Sponsor
Baylor Research Institute
Study Sponsor
Carolyn Matthews, MD, Principal Investigator, Baylor Research Institute/Texas Oncology
Verification Date
March 2016