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

NCT02554344 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 015-074
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

CIN3; Squamous CIN3

Outcome Measures

Primary Outcomes (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.

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

  4 months

Secondary Outcomes (5)

• Regression Rate

  4 months

• Overall Response

  4 months

• Pathologic Response

  4 months

• Rate of patients in which p65, phosphorylated p65, and acetylated p65 play a role in the persistence of CIN.

  4 months

• Evaluation of patients with CIN3 for the presence of high-risk HPV.

  4 months

Study Arms (1)

All Patients

EXPERIMENTAL

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

Interventions

Curcumin DRUG

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

Also known as: Turmeric, BCM-95®

All Patients

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Carolyn Matthews, MD

  Baylor Research Institute/Texas Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 18, 2015
• Study Start: June 22, 2015
• Primary Completion: July 11, 2017
• Study Completion: July 11, 2017
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (1)