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

February 15, 2021 updated by: Barretos Cancer Hospital

Ensaio clínico Randomizado Avaliando a eficácia do Tratamento tópico Com Imiquimode em lesões Intraepiteliais Cervicais de Alto Grau

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Barretos, Brazil
        • Barretos Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • loop electrosurgical excision procedure
  • Conization of the cervix
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:
  • loop electrosurgical excision procedure
  • Conization of the cervix
Drug: Imiquimod
Application by the doctor of immunomodulatory cream on the uterine cervix 1 time per week for 12 weeks
Other Names:
  • Imiquimod 5% cream
  • Ixium 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 months
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.
30 months
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
30 months
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.
24 months
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.
24 months
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.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Collaborators

Farmoquimica S.A.

Investigators

  • Study Director: Ricardo D Reis, PhD, Barretos Cancer Hospital
  • Principal Investigator: Bruno DO Fonseca, MD, Barretos Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 14, 2020

Study Completion (Actual)

January 14, 2020

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 28, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BarretosCH-20171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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