MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)

Human Papillomavirus (HPV) is causally associated with cervical cancer and precancerous lesions (dysplasias) of the cervix. These lesions are detected mainly in the transformation zone and are diagnosed with colposcopy and biopsy confirmation. In high-grade lesions conization (surgical removal of a cone tissue form the cervix) is the therapy of choice, but in low-grade lesions monitoring and no-treatment is preferred. However, this wait-and-see approach can be assisted by pharmaceutical treatment, like MODUCARE.

MODUCARE is classified as a natural dietary supplement, specifically an immune support supplement containing a patented blend of plant sterols and sterolins, primarily beta-sitosterol and beta-sitosterol glucoside, derived from plant sources. It is taken orally, 2 capsules three times daily for the first month and then 1 capsule three times daily for next 5 months (in total 6 months).

Inclusion criteria

• Histologically proven CIN1
• Any HPV status (negative, positive: high or low risk)
• Any Pap test result
• Age 18 - 85 years old
• ECOG Performance status 0 - 1

Exclusion criteria

• Pregnancy
• Low likelihood of patient compliance to treatment protocol and follow-up
• Previous operation to the cervix
• Previous pelvic malignancy
• Pre-existing histologically proven CIN1 > 12 months
• Pre-existing histologically proven CIN2 and/or CIN3
• Hypersensitivity to trial medication