Cervical Intraepithelial NeoplasiaEarly Phase 1NCT02554344
Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
A Early Phase 1 study testing Curcumin in people with Cervical Intraepithelial Neoplasia, run by Baylor Research Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2015to 11 Jul 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
About this study
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.
Read the 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.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Curcumin
- Keywords
- CIN3, Squamous CIN3
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called Turmeric, BCM-95®
Patients will receive 500mg of curcumin administered orally, twice a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (5)
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start22 Jun 2015
- Primary completion11 Jul 2017
- Study completion11 Jul 2017
Why it stopped: no subject accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolyn Matthews, MD, Principal investigator, Baylor Research Institute/Texas Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554344
- Sponsor's protocol ID
- 015-074
- Status last verified
- Jan 2026
- First submitted
- 14 Sep 2015
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
- ClinicalTrials.gov ID
- NCT02554344
- Acronym / sponsor ID
- 015-074
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- CIN3, Squamous CIN3
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no subject accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 22 Jun 2015 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Experimental | Drug: CurcuminFourteen 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: Turmeric, BCM-95®Patients will receive 500mg of curcumin administered orally, twice a day for 12 weeks. | Drug | All Patients |
Primary outcome
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.
5 secondary outcomes
Regression Rate
Time frame: 4 months
Overall Response
Time frame: 4 months
Pathologic Response
Time frame: 4 months
Rate of patients in which p65, phosphorylated p65, and acetylated p65 play a role in the persistence of CIN.
Time frame: 4 months
Evaluation of patients with CIN3 for the presence of high-risk HPV.
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Matthews, MD principal investigator
Baylor Research Institute/Texas Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Curcumin in people with Cervical Intraepithelial Neoplasia, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.