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

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ClinicalTrials.gov Identifier: NCT02554344
Recruitment Status : Unknown
Verified March 2016 by Baylor Research Institute.
Recruitment status was:  Recruiting
First Posted : September 18, 2015
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Tracking Information
First Submitted Date  ICMJE September 14, 2015
First Posted Date  ICMJE September 18, 2015
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02554344 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
  • Regression Rate [ Time Frame: 4 months ]
    Determine if treatment with oral curcumin for 12 weeks will cause regression of CIN3. The response will be measured based on histology of the tissue. The location of CIN3 will be documented in the case report form. The degree of CIN3 will be recorded visually as well as histologically through biopsy. The total area will be estimated by the physicians and tissue sections will be made and the degree of dysplasia will be determined.
  • Overall Response [ Time Frame: 4 months ]
    Recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the finding of target disease and will also take into consideration the appearance of new lesions.
  • Pathologic Response [ Time Frame: 4 months ]
    Patients will undergo colposcopy followed by LEEP or CKC if residual dysplasia is still present after treatment. Using standard morphologic criteria, the biopsies will be evaluated, dysplasia will be graded.
  • Rate of patients in which p65, phosphorylated p65, and acetylated p65 play a role in the persistence of CIN. [ Time Frame: 4 months ]
    The minced tissue will be homogenized using a Dounce homogenizer and and centrifuged at 16,000 × g at 4 °C for 10 min. The proteins will be fractionated by SDS-PAGE, electrotransferred to polyvinylidene fluoride (PVDF) membranes, blotted with each antibody sequentially (p65, phosphorylated p65, or acetylated p65; Cell Signaling Technology; Danvers, MA), and detected by enhanced chemiluminescence (Amersham ECL Advance kit; GE Healthcare Life Sciences, Inc, Piscataway, NJ). The PVDF filters will be stripped and re-probed so each blot can be used to measure all three antibodies on the same samples.
  • Evaluation of patients with CIN3 for the presence of high-risk HPV. [ Time Frame: 4 months ]
    HPV tests will be conducted using the AMPLICOR® Human Papillomavirus Test. This is a polymerase chain reaction-based (PCR) qualitative test for the detection of 13 high-risk HPV geneotypes most commonly associated with cervical pre-cancer, including HPV-16 and -18.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Intraepithelial Neoplasia
Intervention  ICMJE Drug: Curcumin
Patients will receive 500mg of curcumin administered orally, twice a day for 12 weeks.
Other Names:
  • Turmeric
  • BCM-95®
Study Arms  ICMJE Experimental: 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: Drug: Curcumin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 17, 2015)
14
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02554344
Other Study ID Numbers  ICMJE 015-074
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baylor Research Institute
Study Sponsor  ICMJE Baylor Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carolyn Matthews, MD Baylor Research Institute/Texas Oncology
PRS Account Baylor Research Institute
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP