A Randomized Trial of MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 182
- 主要终点
- Regression rate of CIN1
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ARM A: Control Arm
Wait-and-See approach
ARM B: Intervention Arm
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)
干预措施: MODUCARE (Dietary Supplement)
结局指标
主要结局
Regression rate of CIN1
时间窗: 6 months after randomization
次要结局
- Regression rate of CIN1(12 months after randomization)
- Progression rate of CIN1(6 & 12 months after randomization)
- Treatment related adverse events(: 6 months after randomization)
研究者
Dimitrios Zouzoulas
Gynecological Oncologist, MSc, PhD, FEBS-BS
Aristotle University Of Thessaloniki