MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1) (MODUCIN1)

Aristotle University Of Thessaloniki

Status: Begins enrollment this month

Conditions: Low-grade Cervical Intraepithelial Neoplasia; Moducare

Treatments: Dietary Supplement: MODUCARE

Study type: Interventional

Funder types: Other

Identifiers

NCT07379905

2025-Β2015-518

Details and patient eligibility

About

MODUCIN-1 (MODUcare for CIN1) is a prospective, single center, open-label, randomized trial that its purpose is to compare MODUCARE versus Wait-and-See Approach for the regression rate of histologically proven low-grade Cervical Intraepithelial Neoplasia (CIN1).

Full description

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).

Enrollment: 182 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

ARM A: Control Arm

No Intervention group

Description:

Wait-and-See approach

ARM B: Intervention Arm

Experimental group

Description:

MODUCARE oral capsules., dosage 2 x 3 for 1 month and 1 x 3 for 5 months (total 6 months, as per instructions provided by the manufacturer)

Treatment:

Dietary Supplement: MODUCARE