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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary: 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.
Sponsor: Baylor Research Institute

Current 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. [ 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Baylor Research Institute

Dates:
Date Received: September 14, 2015
Date Started: March 2016
Date Completion: January 2017
Last Updated: March 16, 2016
Last Verified: March 2016