Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias After 3 Months: a Multicenter, Single-blind, Randomized Controlled Trial
| Registry | NCT03436251, acronym HPV |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 53 (Actual) |
| Sponsor | First Hospital of China Medical University (Other) |
| Conditions | Cervical Intraepithelial Neoplasia, Human Papilloma Virus |
| Interventions | Local Hyperthermia at 37℃, LEEP or cold knife, Local Hyperthermia at 44℃ (Device) |
| Dates | start 2018-01-28, primary completion 2020-05-08, completion 2020-08-01, first posted 2018-02-19, last updated 2021-08-18 |
| Locations | 1 site in China |
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All trials for Cervical Intraepithelial Neoplasia All trials for Human Papilloma Virus All trials of Local Hyperthermia at 37℃ All trials of LEEP or cold knife
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Local Hyperthermia at 44℃ for HPV+/CIN-1 | Experimental | Device: Local Hyperthermia at 44℃ | 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 |
| local hyperthermia at 37℃ for 30 mins | Sham comparator | Device: Local Hyperthermia at 37℃ | HPV+/CIN-1 |
| coniztion of the cervix treatment | Active comparator | Device: LEEP or cold knife | coniztion of cervix for HPV+/CIN2, including LEEP or cold knife coniztion |
| Local Hyperthermia at 44℃ for CIN2/HPV+ | Experimental | Device: Local Hyperthermia at 44℃ | Local hyperthermia at 44℃ for 30 mins at days of 1,2,3 and 17, 18. HPV+ and CIN2. |
Sex: Female, ages: 18 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Yang Yang | Shenyang, Liaoning | China |