The effect of medical grade honey (L-Mesitran) for cervical intraepithelial neoplasia-II

Conditions: cervical dysplasia
pre-cancerous cervical cells
Pre-maligne cervix afwijkingen, CIN II
10038594
10047438

Registration Number: NL-OMON56731

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Women 18-40 years
- Primary CIN II confirmed histologically in the biopsy on colposcopic
examination
- Sufficiënt mastery of the Dutch language

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Simultaneous abnormality in columnar epithelial cells (AIS).
- Hr-HPV negative cytology
- Immunosuppressant use/Autoimmune disease (HIV, CVID)
- History of cervical carcinoma or previous treatment for CIN (LLETZ or
imiquimod)
- Pregnancy or the intention to become pregnant during the study period
(6 months)
- Legal incompetence
- Known allergies to honey

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clearance of hr-HPV at 6 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measure:<br /><br>- Regression of CIN II defined as a regression to Pap1<br /><br>- Clearance of hr-HPV and normalization of cytology (KOPAC) at 12-24 months<br /><br>(depending on NVOG/RIVM flowchart). Histology as in regular care.<br /><br>- Characteristics of the vaginal microbiome; species specific and diversity<br /><br>analysis (T:0 and T:6 months), changes due to honey and relationship with the<br /><br>other outcome measures.<br /><br>- Cervical immune status; immunohistochemical stains (T:0) for T and Myeloid<br /><br>cells (CD4, CD11c, CD168, CD68 and Foxp3). These markers have been used in<br /><br>similar studies of imiquimod in CIN and vulvar HPV lesions.<br /><br>- Human vaginal gene expression profiles (including mRNA inflammatory markers)<br /><br>(T:0 and T:6 months).<br /><br>- Quality of life, side-effects and compliance with the honey.</p><br>