Brief Title
Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias
Official Title
Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias After 3 Months: a Multicenter, Single-blind, Randomized Controlled Trial
Brief 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.
Study Type
Interventional
Primary Outcome
clearance rates of HPV
Secondary Outcome
viral load measurement
Condition
Cervical Intraepithelial Neoplasia
Intervention
Local Hyperthermia at 37℃
Study Arms / Comparison Groups
Local Hyperthermia at 44℃ for HPV+/CIN-1
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
53
Start Date
January 28, 2018
Completion Date
August 1, 2020
Primary Completion Date
May 8, 2020
Eligibility Criteria
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
Female
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Xinghua Gao, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03436251
Organization ID
HH20170606
Responsible Party
Principal Investigator
Study Sponsor
First Hospital of China Medical University
Study Sponsor
Xinghua Gao, Study Director, First Hospital of China Medical University
Verification Date
August 2020