Study of the Effects of Cyclodynon on Reducing the Cumulative Risk of Breast Cancer Development in a Female Aged 40-52

Mammographic Breast Density Clinical Trial

— BIO-CYCL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04498013
• Other study ID #: 453190
• Status: Recruiting
• Phase: Phase 4
• Start date: July 22, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: July 2020
• Source: National University of Pharmacy
• Contact: Tetiana Struk, Ph.D.
• Phone: +380507335050
• Email: struk.tatyana.kh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 52 Years

Eligibility

Inclusion Criteria:

• Female patients aged 40 to 52 years (inclusive) with mastodynia and BI-RADS category 3.

• 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) .

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Mammographic Breast Density

Intervention

Drug:
• Cyclodynon
Cyclodynon 1 tablet a day during 6 menthes period.

Behavioral:
• Lifestyl modification
Measures to normalize the hygiene of work and rest. A diet aimed at achieving an optimal body mass index. Teaching relaxation techniques to increase resistance to chronic stress.

Locations

Country	Name	City	State
Ukraine	Clinical and diagnostics center	Kharkiv

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Struk Tetiana	Bionorica SE

Country where clinical trial is conducted

Ukraine, 

References & Publications (1)

Lee CI, Chen LE, Elmore JG. Risk-based Breast Cancer Screening: Implications of Breast Density. Med Clin North Am. 2017 Jul;101(4):725-741. doi: 10.1016/j.mcna.2017.03.005. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mammographic density	Decrease in the mammographic density determined by a mammographic breast examination at Visit 5 compared to baseline (Visit 1).	6 month
Secondary	BI-RADS indicator	Dynamics of BI-RADS indicator determined by a mammographic breast examination.	6 month