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
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia||Drug: Curcumin||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
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.
Patients will receive 500mg of curcumin administered orally, twice a day for 12 weeks.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554344
|Contact: Grace Townsendfirstname.lastname@example.org|
|Contact: Gaby Ethington||214-818-8326||gabriele@BaylorHealth.edu|
|United States, Texas|
|Baylor Charles A. Sammons Cancer Center||Recruiting|
|Dallas, Texas, United States, 75246|
|Contact: Grace Townsend 214-818-8382 email@example.com|
|Contact: Gaby Ethington 214-818-8326 gabriele@BaylorHealth.edu|
|Principal Investigator: Carolyn Matthews, MD|
|Principal Investigator:||Carolyn Matthews, MD||Baylor Research Institute/Texas Oncology|