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

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

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.

Study Overview

• Status: Unknown
• Conditions: Mammographic Breast Density
• Intervention / Treatment: Drug: Cyclodynon; Behavioral: Lifestyl modification

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tetiana Struk, Ph.D.; Phone Number: +380507335050; Email: struk.tatyana.kh@gmail.com
• Study Contact Backup: Name: Popov Alexet, Ph.D; Phone Number: +380973631791; Email: oleksii.s.popov@gmail.com

Study Locations

• Ukraine
  • Kharkiv, Ukraine, 61057
    • Recruiting
    • Clinical and diagnostics center
    • Contact: Tetiana Struk, Ph.D; Phone Number: +380507335050; Email: struk.tatyana.kh@gmail.com
    • Contact: Oleksii Popov, Ph.D; Phone Number: +380973631791; Email: oleksii.s.popov@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 52 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Patients will be treated with Cyclodynon 1 tablet per day 6 month in addition to lifestyle modification	Drug: Cyclodynon; Cyclodynon 1 tablet a day during 6 menthes period.; Other Names: Chaste Berry (Vitex agnus-castus) Extact , 4 mg.; 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.
Other: Control group; Lifestyle modification only	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mammographic density	Decrease in the mammographic density determined by a mammographic breast examination at Visit 5 compared to baseline (Visit 1).	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BI-RADS indicator	Dynamics of BI-RADS indicator determined by a mammographic breast examination.	6 month

Collaborators and Investigators

• Sponsor: Dr. Struk Tetiana
• Collaborators: Bionorica SE
• Investigators: Principal Investigator: Tetiana Struk, Ph.D, NFAU

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 453190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No