Randomized Clinical Trial Evaluating the Efficacy of Topical Imiquimod in High Grade Cervical Intraepithelial Lesions
Condition: High Grade Intraepithelial Neoplasia; Cervix Cancer
MeSH terms: Neoplasms; Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Control; Imiquimod
Intervention type(s): Procedure; Drug
Intervention description(s): Exertion of the cervix transformation zone; Application by the doctor of immunomodulatory cream on the uterine cervix 1 time per week for 12 weeks
Other intervention name(s): loop electrosurgical excision procedure; Conization of the cervix; Imiquimod 5% cream; Ixium 5%
Intervention MeSH terms: Imiquimod
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients between 25 and 50 years old with histological diagnosis of high-grade intraepithelial lesion, obtained through satisfactory colposcopy and without previous treatment, who will be selected in the preventive clinic of the Hospital de Cancer de Barretos-SP (HCB ). Eligible patients will be identified at the return visit, when they will come to the hospital to check the result of the examination. In this study the patients will be randomized into two groups: Group 1: Control, where standard treatment will be offered, which is the conization of the uterine cervix with loop electrosurgical excision procedure(LEEP); Group 2: experimental group, which will receive topical treatment in the uterine cervix with immunomodulator (Imiquimod), for a period of 12 weeks, with weekly applications (1x / week). 30 to 60 days after immunomodulatory treatment the patient will be submitted to standard treatment with cervical conization with LEEP.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: high grade cervical intraepithelial neoplasia; Immunomodulatory treatment