Randomized Clinical Trial Evaluating the Efficacy of Topical Imiquimod in High Grade Cervical Intraepithelial Lesions
Study Details
Study Description
Brief Summary
Cervical cancer is one of the leading malignancies affecting women, with 311,000 deaths in 2018, most of them seen in underdeveloped countries. This neoplasm has a pre-invasive state, such as cervical intraepithelial neoplasia (CIN), which is caused by HPV (Human Papillomavirus) infection. The female organism most often is able to eliminate the virus, especially in young patients. However, when the infection becomes persistent, especially for subtypes 16 and 18, the risk of CIN developing an increased. Cytological screening programs can efficiently and wirelessly do this. As high-grade intraepithelial lesions (CIN 2/3) are as demonstrated by worse regression rate, only 13.3% at one year, and higher risk for progression to invasive cancer. As CIN 2/3 need treatment, and as more therapies as they are excisional, which theoretically are better, however, they may compromise the reproductive future of women who are unthreatened, increasing the risk of preterm labor, premature rupture of amniotic membranes, low weight Birth and perinatal mortality. This relationship aroused interest in seeking alternative therapies. Decrease antiviral activity directed against HPV, associated with a higher rate of elimination of the infection. Immediate, an agent that stimulates like dendritic cells to producer cytokines and activates epithelial T cells. Imiquimode, when used in vulvar neoplasias, has been shown to be effective, presenting satisfactory results without treatment of CIN 2/3 of the uterine cervix, requiring a better scientific compilation. Based on these data, this study aims to evaluate the efficacy of topical immunomodulatory treatment for high-grade cervical intraepithelial lesions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Control Will be offered the standard treatment, which is the conization of the uterine cervix with loop electrosurgical excision procedure (LEEP). |
Procedure: Control
Exertion of the cervix transformation zone
Other Names:
|
| Experimental: Imiquimod Will receive topical uterine cervix (Imiquimod) treatment for a period of 12 weeks with weekly applications (1x / week). 30-60 days afterwards they will be submitted to standard treatment with conization of the uterine cervix with loop electrosurgical excision procedure (LEEP). |
Procedure: Control
Exertion of the cervix transformation zone
Other Names:
Drug: Imiquimod
Application by the doctor of immunomodulatory cream on the uterine cervix 1 time per week for 12 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Efficacy of immunomodulatory treatment with Imiquimod in high grade intraepithelial lesions of the cervix compared to standard electrosurgical excision procedure (LEEP) treatment. [30 months]
We will evaluate the efficacy of the Imiquimod treatment applied by the physician after histological examination of the uterine cervix obtained by electrosurgical excision procedure (LEEP) and compare the rate of relapse / reoperation with the control patient only submitted to the standard treatment with LEEP
Secondary Outcome Measures
- Local and systemic adverse events [30 months]
To assess the local and systemic adverse effects of topical immunomodulatory treatment through anamnesis and physical examination.
- Compare CIN 2 and CIN 3 for the difference in response to immunomodulatory treatment [30 months]
It will be evaluated separately from the results of the treatment response with Imiquimod in CIN 2 and CIN 3 lesions.
- Definition of the difference in cost from actual standard treatment compared to Imiquimod [30 months]
The value in Brazilian reais of treatment with Imiquimod will be defined as compared to the amount spent for the standard treatment with LEEP
- Evaluation of recurrence of high grade cervical squamous intraepithelial lesion after 2 years of treatment. [24 months]
To evaluate the recurrence after 2 years of the end of the immunomodulatory topical treatment.
- Evaluation of reoperation rate after immunomodulatory treatment associated with standard treatment with LEEP compared to LEEP alone. [24 months]
Evaluation of reoperation rate in post-treatment follow-up.
- Clearance HPV [30 months]
To evaluate the persistence or not of the HPV virus and which specific type to relate to the efficacy of the immunomodulatory treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women between the ages of 25 and 50 with histological diagnosis of CIN 2/3;
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Living 300 km or less from the city of Barretos-São Paulo / Brazil.
Exclusion Criteria:
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Suspected adenocarcinoma (in situ or invasive) or invading squamous cell carcinoma by colposcopy and/or citology;
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Being pregnant or breastfeeding;
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Women with some immunodeficiency or transplanted;
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Previous treatment history for CIN 2/3.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barretos Cancer Hospital | Barretos | Brazil |
Sponsors and Collaborators
- Barretos Cancer Hospital
- Farmoquimica S.A.
Investigators
- Study Director: Ricardo D Reis, PhD, Barretos Cancer Hospital
- Principal Investigator: Bruno DO Fonseca, MD, Barretos Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BarretosCH-20171