Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias

Cervical Intraepithelial Neoplasia Clinical Trial

— HPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436251
• Other study ID #: HH20170606
• Status: Completed
• Phase: N/A
• Start date: January 28, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: First Hospital of China Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 1, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Fever
• Human Papilloma Virus
• Neoplasms
• Papilloma

Intervention

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

Locations

Country	Name	City	State
China	Yang Yang	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clearance rates of HPV	to evaluate the clearance rates in different treatment groups 3 month after treatment.	3 months after the last time of treatment.
Primary	scoring atypia by cytology/pathology	to evaluate atypia severity score of cervical cells 3 month after treatment.	3 months after the last time of treatment.
Secondary	viral load measurement	to measure the HPV 16 viral load after 3 month of treatment	3 months after the last time of treatment.