Evaluation of Oral EGCG Treatment for L-SIL Associated With HPV Infection (EGCG-HPV)

March 10, 2024 updated by: Antonio Simone Laganà, University of Palermo

Evaluation of Oral Epigallocatechin Gallate Treatment for Low-grade Cervical Lesions (L-SIL) Associated With Human Papilloma Virus (HPV) Infection

The study aims to evaluate the effectiveness of the synergy of oral Epigallocatechin Gallate as a treatment for Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) infection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Human papilloma virus (HPV) infection is the most widespread infection worldwide among the sexually active population. Papillomaviruses are a very large and heterogeneous family of double-stranded DNA viruses (8kb). They have no envelope and have icosahedral symmetry. Their viral genome is divided into two regions defined as 1) early and 2) late. The early genes encode the early proteins E1, E2, E4, E5, E6, E7 necessary for viral DNA replication and cellular transformation. The late genes encode the late proteins L1, L2 which serve for the formation of the viral capsid. HPV viruses are classified based on their oncogenicity. Those at low risk are associated with proliferative lesions, generally benign, of the skin and mucous membranes. The clinical manifestations include common, flat and plantar warts, genital and flat condylomata acuminata which are the result of sexual transmission of the virus and which arise on the penis, anus, female genitalia, urethra, perianal area and straight. High-risk HPVs, on the other hand, are those that integrate into the host's genome and cause lesions that can evolve into carcinoma over time. However, it has recently been shown that even viruses normally defined as low risk can cause precancerous lesions in the case of tumors of the vulva, vagina, penis and anus. In 80% of cases the infection resolves spontaneously within two years, however in 20% of cases, the infection persists and causes the onset of lesions of varying degrees which over time can evolve into neck cancer of the uterus in women or penile cancer in men. In fact, if HPV is now recognized as the etiological agent of cervical cancer in 99.7% of cases, it is estimated that it is also responsible for 50% of penile tumors and 26-30% of cord tumors oral.

Persistence therefore represents an oncological risk factor for those who contract the infection, since if the infection persists for over a year, there is a high probability that the viral DNA integrates into the host's genome. Integration involves the constitutive expression of some viral oncoproteins (E6/E7) that block the activity of host tumor suppressor genes (p53/pRB). The blockade of tumor suppressors in turn stimulates an uncontrolled proliferation of lesions, which, due to a failure to activate the inhibitory regulatory processes of our organism, leads to tumor development.

In the case of lesions classified as "low grade" (L-SIL), the common practice is to check the patient after six months, while in the case of lesions classified as "high grade" (H-SIL), the therapeutic standard is represented by the surgical removal of these lesions. However, removal of the lesion does not guarantee total eradication of the infection, as the virus could persist in the adjacent healthy mucosa. Currently, there are no treatments against HPV infection, nor against the persistence of the virus. Various types of therapies are associated with primary (vaccination) and secondary (screening programs) prevention programs for the treatment of clinical manifestations induced by the virus, such as warts. Among the treatments that are used as normal clinical practice in the field of HPV infections, also for the treatment of warts, those based on epigallocatechin gallate (EGCG) represent a novelty that has been proven to be safe and effective.

Epigallocatechin gallate (EGCG), the main polyphenolic component of green tea, has antioxidant, anti-inflammatory and anticancer properties. Its action has also been extensively tested on cervical cancer lines, on which EGCG exerts an antiproliferative and pro-apoptotic action in a dose-dependent manner. A recent study demonstrated that EGCG increases the expression levels of p53 protein and reduces the levels of viral oncoproteins E6/E7. A randomized clinical trial has also highlighted how treatment with EGCG has a chemo-preventive action on the progression of lesions in HPV-positive women with lesions of various degrees, leading to a reduction in the degree of the lesions themselves.

Considering these elements, the study aims to evaluate the effectiveness of the synergy of oral Epigallocatechin Gallate as a treatment for Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) infection.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • Recruiting
        • "Paolo Giaccone" Hospital
        • Contact:
        • Sub-Investigator:
          • Pietro Serra, M.D.
        • Sub-Investigator:
          • Giuseppe Mascellino, M.D.
        • Sub-Investigator:
          • Andrea Etrusco, M.D.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women affected by Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) Infection

Description

Inclusion Criteria:

  • Women affected by Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) Infection

Exclusion Criteria:

  • Pregnancy
  • Concomitant pathologies causing immunosuppression
  • Concurrent Immunomodulatory therapies
  • Hormone replacement therapy
  • High-grade Cervical Lesions (H-SIL) or in situ adenocarcinoma
  • Previous history of L-SIL or higher grade lesions ≥ 24 months

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low-grade Cervical Lesions (L-SIL)
Women affected by Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) Infection
Dietary supplement: Epigallocatechin Gallate
Oral treatment with Epigallocatechin Gallate 200 mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence
Time Frame: After 6, 12, 18, and 24 months from the recruitment
Persistence of Low-grade Cervical Lesions (L-SIL), evaluated by pap smear
After 6, 12, 18, and 24 months from the recruitment

Collaborators and Investigators

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

Sponsor

University of Palermo

Investigators

  • Principal Investigator: Antonio Simone Laganà, M.D., Ph.D., University of Palermo
  • Study Chair: Andrea Etrusco, M.D., University of Palermo
  • Study Chair: Pietro Serra, M.D., University of Palermo
  • Study Chair: Giuseppe Mascellino, M.D., University of Palermo

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)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 10, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGCG-HPV

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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