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

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02554344
• Other study ID #: 015-074
• Status: Recruiting
• Phase: Phase 0
• First received: September 14, 2015
• Last updated: March 16, 2016
• Start date: March 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2016
• Source: Baylor Research Institute
• Contact: Grace Townsend
• Phone: 214-818-8382
• Email: grace.townsend[@]baylorhealth.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Drug:
• Curcumin
Patients will receive 500mg of curcumin administered orally, twice a day for 12 weeks.

Locations

Country	Name	City	State
United States	Baylor Charles A. Sammons Cancer Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months	Yes
Secondary	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.	4 months	No
Secondary	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.	4 months	No
Secondary	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.	4 months	No
Secondary	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.	4 months	No
Secondary	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.	4 months	No