Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2016 |
| End Date: | January 2017 |
| Contact: | Grace Townsend |
| Email: | grace.townsend@baylorhealth.edu |
| Phone: | 214-818-8382 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Dallas, Texas 75246
Principal Investigator: Carolyn Matthews, MD
Phone: 214-818-8382
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