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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Drug: Curcumin Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Curcumin
Patients will receive 500mg of curcumin administered orally, twice a day for 12 weeks.
Other Names:
  • Turmeric
  • BCM-95®


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Grace Townsend 214-818-8382 grace.townsend@baylorhealth.edu
Contact: Gaby Ethington 214-818-8326 gabriele@BaylorHealth.edu

Locations
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United States, Texas
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Grace Townsend    214-818-8382    grace.townsend@baylorhealth.edu   
Contact: Gaby Ethington    214-818-8326    gabriele@BaylorHealth.edu   
Principal Investigator: Carolyn Matthews, MD         
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Carolyn Matthews, MD Baylor Research Institute/Texas Oncology
More Information
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02554344    
Other Study ID Numbers: 015-074
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by Baylor Research Institute:
CIN3
Squamous CIN3
Additional relevant MeSH terms:
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Uterine Cervical Dysplasia
Uterine Cervical Diseases
Curcumin
Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action