Randomized Clinical Trial Evaluating the Efficacy of Topical Imiquimod in High Grade Cervical Intraepithelial Lesions

Barretos Cancer Hospital

Status and phase: Completed; Phase 2

Conditions: High Grade Intraepithelial Neoplasia; Cervix Cancer

Treatments: Drug: Imiquimod; Procedure: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03233412

BarretosCH-20171

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Control

Other group

Description:

Will be offered the standard treatment, which is the conization of the uterine cervix with loop electrosurgical excision procedure (LEEP).

Treatment:

Procedure: Control

Imiquimod

Experimental group

Description:

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).

Treatment:

Procedure: Control

Drug: Imiquimod