Mammographic Breast DensityPhase 4BIO-CYCLNCT04498013
Study of the Effects of Cyclodynon on Reducing the Cumulative Risk of Breast Cancer Development in a Female Aged 40-52
A Phase 4 study testing Cyclodynon and Lifestyl modification in people with Mammographic Breast Density, run by Dr. Struk Tetiana at 1 site in Ukraine.
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. Read more about this study
- Who is it for?
- Ages 40 to 52 years, women only
- Conditions the study is for
- Mammographic Breast Density
- What is being tested?
- Cyclodynon and Lifestyl modification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUkraine
- Study dates
- 22 Jul 2020to 1 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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) .
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
Clinical and diagnostics center
Kharkiv, 61057
Tetiana Struk, Ph.D, +380507335050, struk.tatyana.kh@gmail.com
Oleksii Popov, Ph.D, +380973631791, oleksii.s.popov@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Mammographic Breast Density
- Being tested
- Cyclodynon, Lifestyl modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclodynonDrug
Also called Chaste Berry (Vitex agnus-castus) Extact , 4 mg.
Cyclodynon 1 tablet a day during 6 menthes period.
Lifestyl modificationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients will be treated with Cyclodynon 1 tablet per day 6 month in addition to lifestyle modification Receives: Drug: Cyclodynon; Behavioral: Lifestyl modification |
| Control group | Other | Lifestyle modification only Receives: Behavioral: Lifestyl modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammographic density
Decrease in the mammographic density determined by a mammographic breast examination at Visit 5 compared to baseline (Visit 1).
Measured: 6 month
Secondary outcomes (1)
BI-RADS indicator
Dynamics of BI-RADS indicator determined by a mammographic breast examination.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start22 Jul 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mammographic Breast DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Struk Tetiana
- Sponsor type
- University, hospital or other
- Collaborators
- Bionorica SE
- Responsible party
- Sponsor-investigator, Dr. Struk Tetiana, National University of Pharmacy
- Investigators
- Tetiana Struk, Ph.D, Principal investigator, NFAU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498013
- Sponsor's protocol ID
- 453190
- Acronym
- BIO-CYCL
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28577623
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04498013
- Acronym / sponsor ID
- BIO-CYCL / 453190
- Conditions
- Mammographic Breast Density
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dr. Struk TetianaUniversity, hospital or other
- Collaborators
- Bionorica SE
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Cyclodynon, Behavioral: Lifestyl modificationPatients will be treated with Cyclodynon 1 tablet per day 6 month in addition to lifestyle modification |
| Control group | Other | Behavioral: Lifestyl modificationLifestyle modification only |
Who may qualify
- Ages
- 40 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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) .
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclodynonAlso: Chaste Berry (Vitex agnus-castus) Extact , 4 mg.Cyclodynon 1 tablet a day during 6 menthes period. | Drug | Treatment group |
| Lifestyl modificationMeasures 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. | Behavioural | Control group, Treatment group |
Primary outcome
Mammographic density
Time frame: 6 month
Decrease in the mammographic density determined by a mammographic breast examination at Visit 5 compared to baseline (Visit 1).
1 secondary outcome
BI-RADS indicator
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Background: PubMed 28577623Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetiana Struk, Ph.D principal investigator
NFAU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclodynon and Lifestyl modification in people with Mammographic Breast Density, run by Dr. Struk Tetiana at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tetiana Struk, Ph.D. (+380507335050, struk.tatyana.kh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammographic density (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.