Cervical Intraepithelial Neoplasia-II, High Risk Human Papillomavirus
Conditions
Keywords
Honey CINII
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.
Interventions
DRUGMedical grade honey formulation (MGH) (L-Mesitran®)
Daily application of 5 grams (with applicator) for the first 3 months, followed by weekly application of 5 grams for the following 3 months.
Sponsors
Zuyderland Medisch Centrum
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of hr-HPV | 6 months | The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of hr-HPV and normalization of cytology (KOPAC) | 12-24 months | Normalization of cytology (KOPAC) (depending on NVOG/RIVM flowchart). |
| Characteristics of the vaginal microbiome | 0-6 months | Species specific and diversity analysis, changes due to honey and relationship with the other outcomes measures |
| Regression of CIN II | 12-24 months | Defined as a regression to Pap 1 |
| Human vaginal gene expression profiles | 0 and 6 months | RNA quantity and quality of 20 patients |
| Quality of life, side-effects and compliance with medical grade honey | 0, 6, 12 and 24 months | — |
| Cervical immune status | 0 months | Immunohistochemical stains on colposcopy biopsies for T and Myeloid cells |
Countries
Netherlands
Contacts
Primary ContactJordy Mongula, dr.
Backup ContactJasmijn Prop, Drs.
Outcome results
None listed