Local Hyperthermia for the Treatment of Cervical Persistent High-risk Infection

NCT ID: NCT07059819

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-02
• Study Completion Date: 2026-10-01

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 utilized 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 HR-HPV in cervical area. So the purpose of the study is to evaluate the effective of local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months. Appropriate control arms were designed for different conditions.

Conditions

Cervical Intraepithelial Neoplasia (CIN); Human Papillovirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Local Hyperthermia

Group Type: EXPERIMENTAL

Local hyperthermia device

Intervention Type: DEVICE

Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18.

Placebo

Group Type: PLACEBO_COMPARATOR

Local hyperthermia device

Intervention Type: DEVICE

Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18.

Interventions

Local hyperthermia device

Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18-65 years old; generally healthy gynecological conditions, normal sexual life; high risk HPV for persistent at least 3 months; 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

Locations

the First Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

HH20241031

Identifier Type: -

Identifier Source: org_study_id