Clinical trial · Interventional
Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
NCT02554344CI-TRIAL-00102065withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no subject accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curcumin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All Patients
- 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.
- interventionNames
- Drug: Curcumin
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 4 months
- description
- Events will be recorded from the time of informed consent signature through the 30 days following the last study treatment.
Secondary outcomes (5)
- measure
- Regression Rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.