Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias

Overview

Human papillomavirus(HPV) infect epithelial cells and have the capacity to stimulate cell abnormal hyperplasia, especially by those high-risk HPV types. HPV vaccine primarily targeting HPV6/11/16/18 has been available and makes it possible to prevent cervical cancer. However, a large population was left unvaccinated, specifically for those aged ones. In clinic, patients harboring high-risk HPV is quite prevalent in China or other developing nations. Removing the virus and prevention of malignant transformation is required. Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months, with positive high-risk type HPVs, and patients with positive testing for high risk HPVs. Appropriate control arms were designed for different conditions.

Full Title of Study: “Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias After 3 Months: a Multicenter, Single-blind, Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 8, 2020

Detailed Description

Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months, with positive high-risk type HPVs, and patients with positive testing for high risk HPVs. Appropriate control arms were designed for different conditions. One control arm is local hyperthermia at 37°C for 30 mins targeted for CINⅠ, the other control arm is LEEP targeted for CINⅡ. After 3 months, to evaluate the effectivity of local hyperthermia.

Interventions

  • Device: Local Hyperthermia at 37℃
    • As a control, for patients with HPV+/CIN-1 or HPV+ with normal cytology, hyperthermia at 37℃ is applied
  • Device: LEEP or cold knife
    • For patients with HPV+ / CIN-2
  • Device: Local Hyperthermia at 44℃
    • As an experimental arm, for patients with HPV+/CIN-1/CIN2 or HPV+ with normal cytology

Arms, Groups and Cohorts

  • Experimental: Local Hyperthermia at 44℃ for HPV+/CIN-1
    • Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18. HPV+ and normal cytology or HPV+/CIN-1
  • Sham Comparator: local hyperthermia at 37℃ for 30 mins
    • HPV+/CIN-1
  • Active Comparator: coniztion of the cervix treatment
    • coniztion of cervix for HPV+/CIN2, including LEEP or cold knife coniztion
  • Experimental: Local Hyperthermia at 44℃ for CIN2/HPV+
    • Local hyperthermia at 44℃ for 30 mins at days of 1,2,3 and 17, 18. HPV+ and CIN2.

Clinical Trial Outcome Measures

Primary Measures

  • clearance rates of HPV
    • Time Frame: 3 months after the last time of treatment.
    • to evaluate the clearance rates in different treatment groups 3 month after treatment.
  • scoring atypia by cytology/pathology
    • Time Frame: 3 months after the last time of treatment.
    • to evaluate atypia severity score of cervical cells 3 month after treatment.

Secondary Measures

  • viral load measurement
    • Time Frame: 3 months after the last time of treatment.
    • to measure the HPV 16 viral load after 3 month of treatment

Participating in This Clinical Trial

Inclusion Criteria

  • 18-65 years old; generally healthy gynecological conditions, normal sexual life; high risk HPV; Cervical biopsy CIN or no cytological changes; signed informed consent Exclusion Criteria:
  • Pregnant woman;local or systematic treatment within 3 months; Comorbidity of other severe gynecological inflammation, infection, or tumor; Comorbidity of other serious illnesses; no guarantee of timely treatment and follow-up
  • Gender Eligibility: Female

    Minimum Age: 18 Years

    Maximum Age: 65 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • First Hospital of China Medical University
    • Provider of Information About this Clinical Study
      • Principal Investigator: Gao Xinghua, professor – First Hospital of China Medical University
    • Overall Official(s)
      • Xinghua Gao, Study Director, First Hospital of China Medical University

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