Effect of Honey For CIN II (HoneyForCINII)

Zuyderland Medisch Centrum

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Cervical Intraepithelial Neoplasia-II; High Risk Human Papillomavirus

Treatments: Drug: Medical grade honey formulation (MGH) (L-Mesitran®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06219018

NL86044.096.23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II

Experimental group

Description:

Daily application of 5 grams (with applicator) for 3 months. Then weekly application (5 grams with applicator) for 3 months.

Treatment:

Drug: Medical grade honey formulation (MGH) (L-Mesitran®)