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

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Curcumin
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring CIN3, Squamous CIN3

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Baylor Charles A. Sammons Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Patients

Arm 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.

Outcomes

Primary Outcome Measures

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.
Events will be recorded from the time of informed consent signature through the 30 days following the last study treatment.

Secondary Outcome Measures

Regression Rate
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
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
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.
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.
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.

Full Information

First Posted
September 14, 2015
Last Updated
March 16, 2016
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02554344
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
Keywords
CIN3, Squamous CIN3

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All Patients
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Curcumin
Other Intervention Name(s)
Turmeric, BCM-95®
Intervention Description
Patients will receive 500mg of curcumin administered orally, twice a day for 12 weeks.
Primary Outcome Measure Information:
Title
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.
Description
Events will be recorded from the time of informed consent signature through the 30 days following the last study treatment.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Regression Rate
Description
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.
Time Frame
4 months
Title
Overall Response
Description
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.
Time Frame
4 months
Title
Pathologic Response
Description
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.
Time Frame
4 months
Title
Rate of patients in which p65, phosphorylated p65, and acetylated p65 play a role in the persistence of CIN.
Description
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.
Time Frame
4 months
Title
Evaluation of patients with CIN3 for the presence of high-risk HPV.
Description
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.
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient will be eligible for inclusion in this study if she meets all of the following criteria: The patient must be 21 or older and able to give informed consent. Patient must have histologically confirmed squamous CIN3. There must be an adequate colposcopy. Patient must have no abnormal cells in their endocervical curettage (ECC). 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: Women who are pregnant or lactating. HIV+ status Adenocarcinoma in situ or any invasive cancer of the cervix. Gallstones or bile duct obstructions. Patients on anti-coagulant/anti-platelet therapies. Patients on immunosuppressive therapies. Patients may not receive any other investigational treatments while participating in this study. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Townsend
Phone
214-818-8382
Email
grace.townsend@baylorhealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gaby Ethington
Phone
214-818-8326
Email
gabriele@BaylorHealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Matthews, MD
Organizational Affiliation
Baylor Research Institute/Texas Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Townsend
Phone
214-818-8382
Email
grace.townsend@baylorhealth.edu
First Name & Middle Initial & Last Name & Degree
Gaby Ethington
Phone
214-818-8326
Email
gabriele@BaylorHealth.edu
First Name & Middle Initial & Last Name & Degree
Carolyn Matthews, MD

12. IPD Sharing Statement

Learn more about this trial

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

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