Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias

NCT ID: NCT03436251

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-28
• Study Completion Date: 2020-08-01

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.

Conditions

Cervical Intraepithelial Neoplasia; Human Papilloma Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Local Hyperthermia at 44℃

Intervention Type: DEVICE

As an experimental arm, for patients with HPV+/CIN-1/CIN2 or HPV+ with normal cytology

local hyperthermia at 37℃ for 30 mins

HPV+/CIN-1

Group Type: SHAM_COMPARATOR

Local Hyperthermia at 37℃

Intervention Type: DEVICE

As a control, for patients with HPV+/CIN-1 or HPV+ with normal cytology, hyperthermia at 37℃ is applied

coniztion of the cervix treatment

coniztion of cervix for HPV+/CIN2, including LEEP or cold knife coniztion

Group Type: ACTIVE_COMPARATOR

LEEP or cold knife

Intervention Type: DEVICE

For patients with HPV+ / CIN-2

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.

Group Type: EXPERIMENTAL

Local Hyperthermia at 44℃

Intervention Type: DEVICE

As an experimental arm, for patients with HPV+/CIN-1/CIN2 or HPV+ with normal cytology

Interventions

Local Hyperthermia at 37℃

As a control, for patients with HPV+/CIN-1 or HPV+ with normal cytology, hyperthermia at 37℃ is applied

Intervention Type: DEVICE

LEEP or cold knife

For patients with HPV+ / CIN-2

Intervention Type: DEVICE

Local Hyperthermia at 44℃

As an experimental arm, for patients with HPV+/CIN-1/CIN2 or HPV+ with normal cytology

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Gao Xinghua

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinghua Gao

Role: STUDY_DIRECTOR

First Hospital of China Medical University

Locations

Yang Yang

Shenyang, Liaoning, China

Countries

China

References

Yang Y, Zhang L, Zhang Y, Huo W, Qi R, Guo H, Li X, Wu X, Bai F, Liu K, Qiao Y, Piguet V, Croitoru D, Chen HD, Gao XH. Local Hyperthermia at 44 degrees C Is Effective in Clearing Cervical High-Risk Human Papillomaviruses: A Proof-of-Concept, Randomized Controlled Clinical Trial. Clin Infect Dis. 2021 Nov 2;73(9):1642-1649. doi: 10.1093/cid/ciab369.

Reference Type: DERIVED

PMID: 33905482 (View on PubMed)

Other Identifiers

HH20170606

Identifier Type: -

Identifier Source: org_study_id