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.
Full Title of Study: “Ensaio clínico Randomizado Avaliando a eficácia do Tratamento tópico Com Imiquimode em lesões Intraepiteliais Cervicais de Alto Grau”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: August 31, 2019
- Procedure: Control
- Exertion of the cervix transformation zone
- Drug: Imiquimod
- Application by the doctor of immunomodulatory cream on the uterine cervix 1 time per week for 12 weeks
Arms, Groups and Cohorts
- Other: Control
- Will be offered the standard treatment, which is the conization of the uterine cervix with loop electrosurgical excision procedure (LEEP).
- 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).
Clinical Trial Outcome Measures
- Efficacy of immunomodulatory treatment with Imiquimod in high grade intraepithelial lesions of the cervix compared to standard electrosurgical excision procedure (LEEP) treatment.
- Time Frame: 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
- Local and systemic adverse events
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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.
- Time Frame: 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.
- Time Frame: 24 months
- Evaluation of reoperation rate in post-treatment follow-up.
- Clearance HPV
- Time Frame: 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.
Participating in This Clinical Trial
- Women between the ages of 25 and 50 with histological diagnosis of CIN 2/3;
- Living 300 km or less from the city of Barretos-São Paulo / Brazil.
- Suspected adenocarcinoma (in situ or invasive) or invading squamous cell carcinoma by colposcopy and/or citology;
- Being pregnant or breastfeeding;
- Women with some immunodeficiency or transplanted;
- Previous treatment history for CIN 2/3.
Gender Eligibility: Female
Minimum Age: 25 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Barretos Cancer Hospital
- Farmoquimica S.A.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Ricardo D Reis, PhD, Study Director, Barretos Cancer Hospital
- Bruno DO Fonseca, MD, Principal Investigator, Barretos Cancer Hospital
Citations Reporting on Results
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