Breast Fibrocystic DiseasePhase 3NCT00967681
Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease
A Phase 3 study testing Oncoxin in people with Breast Fibrocystic Disease, run by Catalysis SL at 1 site in Cuba.
Trial summary
The purpose of the study is to evaluate whether Oncoxin, a nutritional supplement, improves the clinical and ultrasonographic results in comparison with placebo during 24 weeks of treatment. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Fibrocystic Disease
- What is being tested?
- Oncoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCuba
- Study dates
- Sep 2009to Apr 2011
- Phase
- Phase 3
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical and ultrasonographic confirmation of breast fibrocystic disease.
- Patients older than 20 years.
- Female patients.
- Informed consent.
Who cannot join
- Presents of another disease not well controlled.
- Pregnant women or lactating.
- Patient which are receiving another products from other investigations trials.
Trial locations and contacts
1 site in 1 country.
Cuba1 site
"Ramón González Coro" Gynecologic and Obstetric Hospital
Havana, La Habana, 10400
About this study
Official title: Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease
The purpose of the study is to evaluate whether Oncoxin, a nutritional supplement, improves the clinical and ultrasonographic results in comparison with placebo during 24 weeks of treatment.
- Conditions
- Breast Fibrocystic Disease
- Being tested
- Oncoxin, Placebo
- Medical subject headings
- Fibrocystic Breast Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoxinDietary supplement
(caplets 300 mg), three oral caplets per day for 24 weeks
PlaceboDietary supplement
(caplets 300 mg), three oral caplets per day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Oncoxin, a nutritional supplement Receives: Dietary Supplement: Oncoxin |
| B | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ultrasonographic improvement at 24 weeks (end of the treatment)
Measured: 24 weeks
Adverse effects at 24 weeks (end of the treatment)
Measured: 24 weeks
Secondary outcomes (2)
Lesion size according clinical measurement at 24 weeks (end of the treatment)
Measured: 24 weeks
Pain according patient examination at 24 weeks (end of the treatment)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Fibrocystic DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daisy Hernández, MD, Principal investigator, Ramón González Coro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967681
- Sponsor's protocol ID
- CAT-0901-CU
- Status last verified
- May 2012
- First submitted
- 27 Aug 2009
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease
- ClinicalTrials.gov ID
- NCT00967681
- Acronym / sponsor ID
- CAT-0901-CU
- Conditions
- Breast Fibrocystic Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 28 Aug 2009 (estimated)
- 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.
The purpose of the study is to evaluate whether Oncoxin, a nutritional supplement, improves the clinical and ultrasonographic results in comparison with placebo during 24 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: OncoxinOncoxin, a nutritional supplement |
| B | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinical and ultrasonographic confirmation of breast fibrocystic disease.
- Patients older than 20 years.
- Female patients.
- Informed consent.
Key exclusion criteria (3 listed)
- Presents of another disease not well controlled.
- Pregnant women or lactating.
- Patient which are receiving another products from other investigations trials.
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 |
|---|---|---|
| Oncoxin(caplets 300 mg), three oral caplets per day for 24 weeks | Dietary supplement | A |
| Placebo(caplets 300 mg), three oral caplets per day for 24 weeks | Dietary supplement | B |
Primary outcome
The ultrasonographic improvement at 24 weeks (end of the treatment)
Time frame: 24 weeks
Adverse effects at 24 weeks (end of the treatment)
Time frame: 24 weeks
2 secondary outcomes
Lesion size according clinical measurement at 24 weeks (end of the treatment)
Time frame: 24 weeks
Pain according patient examination at 24 weeks (end of the treatment)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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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.
Daisy Hernández, MD principal investigator
Ramón González Coro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oncoxin in people with Breast Fibrocystic Disease, run by Catalysis SL at 1 site in Cuba.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 4 May 2012. 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 Cuba. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ultrasonographic improvement at 24 weeks (end of the treatment) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2012.