Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias
Condition: Cervical Intraepithelial Neoplasia; Human Papilloma Virus
MeSH terms: Neoplasms; Carcinoma in Situ; Papilloma; Uterine Cervical Dysplasia; Hyperthermia; Fever
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Local Hyperthermia at 37℃; LEEP or cold knife; Local Hyperthermia at 44℃
Intervention type(s): Device; Device; Device
Intervention description(s): As a control, for patients with HPV+/CIN-1 or HPV+ with normal cytology, hyperthermia at 37℃ is applied; For patients with HPV+ / CIN-2; As an experimental arm, for patients with HPV+/CIN-1/CIN2 or HPV+ with normal cytology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperthermia; human papillomavirus virus; cervical intraepithelial neoplasia