NCT03436251

Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: First Hospital of China Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Intraepithelial Neoplasia
• Human Papilloma Virus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-28
• Primary completion: 2020-05-08
• Completion: 2020-08-01
• First posted: 2018-02-19
• Last updated: 2021-08-18

Locations

1 site across 1 country: China