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

NCT04498013 | Unknown Phase 4

• 1 other identifier: 453190
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mammographic Breast Density

Outcome Measures

Primary Outcomes (1)

• Mammographic density

  Decrease in the mammographic density determined by a mammographic breast examination at Visit 5 compared to baseline (Visit 1).

  6 month

Secondary Outcomes (1)

• BI-RADS indicator

  6 month

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients will be treated with Cyclodynon 1 tablet per day 6 month in addition to lifestyle modification

Drug: Cyclodynon; Behavioral: Lifestyl modification

Control group

OTHER

Lifestyle modification only

Behavioral: Lifestyl modification

Interventions

Cyclodynon DRUG

Cyclodynon 1 tablet a day during 6 menthes period.

Also known as: Chaste Berry (Vitex agnus-castus) Extact , 4 mg.

Treatment group

Lifestyl modification BEHAVIORAL

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.

Control group; Treatment group

Eligibility Criteria

• Age: 40 Years - 52 Years
• Gender Eligibility Details: Research refers to the study of a pathological condition that occurs (applicable) only in the female population.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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) .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Struk Tetiana: lead
• Bionorica SE: collaborator

Study Sites (1)

Clinical and diagnostics center

Kharkiv, 61057, Ukraine

RECRUITING

Related 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.

  PMID: 28577623 BACKGROUND

MeSH Terms

Interventions

Vitex agnus castus extract

Study Officials

• Tetiana Struk, Ph.D

  NFAU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tetiana Struk, Ph.D.

CONTACT

+380507335050; struk.tatyana.kh@gmail.com

Popov Alexet, Ph.D

CONTACT

+380973631791; oleksii.s.popov@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: Female patients aged 40 to 52 years (inclusive) with mastodynia and BI-RADS category 3, who meet the requirements of inclusion/exclusion criteria will be randomized in 2 groups. The main group will be treated with Cyclodynon 1 tab per day - 6 month in addition to lifestyle modification. The control group lifestyle modification only. Dynamics of mammographic breast density (changing in BI-RADS score of category 3).

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 4, 2020
• Study Start: July 22, 2020
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)