Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias

NCT03436251 | Completed

• 1 other identifier: HH20170606
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia; Human Papilloma Virus

Keywords

hyperthermia; human papillomavirus virus; cervical intraepithelial neoplasia

Outcome Measures

Primary Outcomes (2)

• clearance rates of HPV

  to evaluate the clearance rates in different treatment groups 3 month after treatment.

  3 months after the last time of treatment.

• scoring atypia by cytology/pathology

  to evaluate atypia severity score of cervical cells 3 month after treatment.

  3 months after the last time of treatment.

Secondary Outcomes (1)

• viral load measurement

  3 months after the last time of treatment.

Study Arms (4)

Local Hyperthermia at 44℃ for HPV+/CIN-1

EXPERIMENTAL

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℃

local hyperthermia at 37℃ for 30 mins

SHAM COMPARATOR

HPV+/CIN-1

Device: Local Hyperthermia at 37℃

coniztion of the cervix treatment

ACTIVE COMPARATOR

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

Device: LEEP or cold knife

Local Hyperthermia at 44℃ for CIN2/HPV+

EXPERIMENTAL

Local hyperthermia at 44℃ for 30 mins at days of 1,2,3 and 17, 18. HPV+ and CIN2.

Device: Local Hyperthermia at 44℃

Interventions

Local Hyperthermia at 37℃ DEVICE

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

local hyperthermia at 37℃ for 30 mins

LEEP or cold knife DEVICE

For patients with HPV+ / CIN-2

coniztion of the cervix treatment

Local Hyperthermia at 44℃ DEVICE

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

Local Hyperthermia at 44℃ for CIN2/HPV+; Local Hyperthermia at 44℃ for HPV+/CIN-1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old; generally healthy gynecological conditions, normal sexual life; high risk HPV; Cervical biopsy CIN or no cytological changes; signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

Yang Yang

Shenyang, Liaoning, 110001, China

Location

Related Publications (1)

• 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.

  PMID: 33905482 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Hyperthermia

Interventions

Conization

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xinghua Gao

  First Hospital of China Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 22, 2017
• First Posted: February 19, 2018
• Study Start: January 28, 2018
• Primary Completion: May 8, 2020
• Study Completion: August 1, 2020
• Last Updated: August 18, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)