Clinical trial NCT06219018: Effect of Honey For CIN II
Official title: The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cervical Intraepithelial Neoplasia-II
High Risk Human Papillomavirus
Keywords: Honey CINII
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this pilot study, we will include 60 patients with newly diagnosed CIN II. Patients will be counseled according to standard guidelines between a LLETZ, imiquimod or expectant management. Patients choosing for expectant management will be asked to participate in the study and will be treated with medical grade honey. Patients choosing for expectant management but not participating in the study and thus not using medicinal honey will be asked for the control arm. Follow-up assessment takes place in accordance with the national guideline (first check-up is after 6 months). In addition, swabs for vaginal microbiota analysis will be taken at 0 and 6 months. Immunohistochemical stainings for the local immune infiltrate will be performed on biopsies taken during regular colposcopy at t=0. This exploratory study aims to investigate the potential effect of honey and provides insight into its mechanisms of action.
Primary purpose: TREATMENT

Brief summary: The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus and an increase in the normalization of CIN II lesions compared to expectant management.

Detailed description: In this pilot study, we will include 60 patients with newly diagnosed CIN II. Patients will be counseled according to standard guidelines between a LLETZ, imiquimod or expectant management. Patients choosing for expectant management will be asked to participate in the study and will be treated with medical grade honey. Patients choosing for expectant management but not participating in the study and thus not using medicinal honey will be asked for the control arm. Follow-up assessment takes place in accordance with the national guideline (first check-up is after 6 months). In addition, swabs for vaginal microbiota analysis will be taken at 0 and 6 months. Immunohistochemical stainings for the local immune infiltrate will be performed on biopsies taken during regular colposcopy at t=0. This exploratory study aims to investigate if there is a potential effect of honey and provides insight into its mechanisms of action.

Eligibility criteria: Inclusion Criteria:

* Women 18-40 years
* Primary CIN II confirmed histologically in the biopsy on colposcopic examination
* Sufficient mastery of the Dutch language

Exclusion Criteria:

* 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
* Legal incompetence
* Known allergies to honey

Primary outcomes:
measure: Clearance of hr-HPV
timeFrame: 6 months
Secondary outcomes:
measure: Regression of CIN II
timeFrame: 12-24 months
measure: Clearance of hr-HPV and normalization of cytology (KOPAC)
timeFrame: 12-24 months
measure: Characteristics of the vaginal microbiome
timeFrame: 0-6 months
measure: Cervical immune status
timeFrame: 0 months
measure: Human vaginal gene expression profiles
timeFrame: 0 and 6 months
measure: Quality of life, side-effects and compliance with medical grade honey
timeFrame: 0, 6, 12 and 24 months
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland MC
state: Limburg
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre+
state: Limburg
Study officials:
References: