A Clinical Study of the Effects of Cyclodynon® Compared With a Control Group on Reducing the Cumulative Risk of Breast Cancer Development in a Female Population Aged 40-52 Years With Mastodynia and BI-RADS Category 3
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Mammographic density
研究概览
简要总结
Increased mammographic density of mammary gland tissues and hyperprolactinaemia are regarded as one of the risk factors for the development of breast cancer in women aged 40 to 52 years, which necessitates closer monitoring of the mammary gland and can be considered as modifiable. The herbal drug Cyclodynone® has a dopaminergic effect on the hypothalamus, which causes its inhibitory effect on the secretion of prolactin. At present, a significant positive clinical and scientific experience has been accumulated in the use of the Cyclodynone® for the treatment of benign breast dysplasias against a background of mild hyperprolactinaemia in women of reproductive age. Demonstration of the positive effect of this drug on the reduction of hyperprolactinemia, mammographic density of MF, evaluation on the scale BI-RADS would justify its application for the modification of this risk factor in women aged 40 to 52 years.
详细描述
Hypothesis
Increased mammographic density of mammary gland tissues and hyperprolactinaemia are regarded as one of the risk factors for the development of breast cancer in women aged 40 to 52 years, which necessitates closer monitoring of the mammary gland. However, this risk factor can be considered as modifiable. The drug Cyclodynone® (contains 4 mg of special extract of dried fruits of Chaste Berry (Vitex agnus-castus)) has a dopaminergic effect on the hypothalamus, which causes its inhibitory effect on the secretion of prolactin. At present, a significant positive clinical and scientific experience has been accumulated in the use of the Cyclodynone® for the treatment of benign breast dysplasias against a background of mild hyperprolactinaemia in women of reproductive age. However, the experience of using Cyclodynone® in women older than 40-52 years with increased density or dyshormonal pathology of breast cancer is limited. Demonstration of the positive effect of this drug on the reduction of hyperprolactinemia, mammographic density of MF, evaluation on the scale BI-RADS would justify its application for the modification of this risk factor in women aged 40 to 52 years.
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
- 40 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 40 to 52 years (inclusive) with mastodynia and BI-RADS category
- •The patient's written informed consent to participate in any study-related procedures.
- •According to the Investigator, the patient's ability to comply with all the requirements of the study protocol, i.e. the patient's ability to cooperate adequately.
- •Patients who do not have chronic diseases of the cardiovascular system, neuroendocrine system, kidneys, liver, gastrointestinal tract, respiratory system, skin in the decompensation stage.
- •Consent to use reliable, evidence-based contraceptive methods (double containing the following types: hormonal, barrier, intrauterine spiral, etc.) throughout the study (from the time of the Informed Consent to Visit 6) .
排除标准
- •Hypersensitivity to the components of the IMP.
- •Burdened history of allergies.
- •Participation in another clinical study less than 90 days before signing the informed consent form.
- •History of cancer.
- •Pregnancy or lactation.
- •Administration of dopamine agonists, dopamine antagonists, oestrogens and antiestrogens, dopamine.
- •Secondary amenorrhoea within 6 months or more.
- •Surgical, pharmacological or physiological menopause (except hysterectomy).
- •The prolactin level is more than 80 ng/mL.
- •Other reasons which make the patient's participation in the study undesirable, according to the Investigator.
研究组 & 干预措施
Treatment group
Patients will be treated with Cyclodynon 1 tablet per day 6 month in addition to lifestyle modification
干预措施: Cyclodynon (Drug)
Treatment group
Patients will be treated with Cyclodynon 1 tablet per day 6 month in addition to lifestyle modification
干预措施: Lifestyl modification (Behavioral)
Control group
Lifestyle modification only
干预措施: Lifestyl modification (Behavioral)
结局指标
主要结局
Mammographic density
时间窗: 6 month
Decrease in the mammographic density determined by a mammographic breast examination at Visit 5 compared to baseline (Visit 1).
次要结局
- BI-RADS indicator(6 month)
研究者
Dr. Struk Tetiana
Associate professor
National University of Pharmacy