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Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias (HPV)

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ClinicalTrials.gov Identifier: NCT03436251
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Gao Xinghua, First Hospital of China Medical University

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.


Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Human Papilloma Virus Device: Local Hyperthermia at 37℃ Device: LEEP or cold knife Device: Local Hyperthermia at 44℃ Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias After 3 Months: a Multicenter, Single-blind, Randomized Controlled Trial
Actual Study Start Date : January 28, 2018
Actual Primary Completion Date : May 8, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
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
Device: Local Hyperthermia at 44℃
As an experimental arm, for patients with HPV+/CIN-1/CIN2 or HPV+ with normal cytology

Sham Comparator: local hyperthermia at 37℃ for 30 mins
HPV+/CIN-1
Device: Local Hyperthermia at 37℃
As a control, for patients with HPV+/CIN-1 or HPV+ with normal cytology, hyperthermia at 37℃ is applied

Active Comparator: coniztion of the cervix treatment
coniztion of cervix for HPV+/CIN2, including LEEP or cold knife coniztion
Device: LEEP or cold knife
For patients with HPV+ / CIN-2

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.
Device: Local Hyperthermia at 44℃
As an experimental arm, for patients with HPV+/CIN-1/CIN2 or HPV+ with normal cytology




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436251


Locations
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China, Liaoning
Yang Yang
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
First Hospital of China Medical University
Investigators
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Study Director: Xinghua Gao First Hospital of China Medical University
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Responsible Party: Gao Xinghua, professor, First Hospital of China Medical University
ClinicalTrials.gov Identifier: NCT03436251    
Other Study ID Numbers: HH20170606
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gao Xinghua, First Hospital of China Medical University:
hyperthermia
human papillomavirus virus
cervical intraepithelial neoplasia
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Papilloma
Cervical Intraepithelial Neoplasia
Fever
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Body Temperature Changes