ClinicalTrials.gg
CompletedNCT00967681Updated May 4, 2012

Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

A Phase 3 interventional study of Oncoxin and Placebo in Breast Fibrocystic Disease, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-05-04.

Sponsored by Catalysis SL · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Fibrocystic Disease
03

In context

Fibrocystic Breast Disease

11 studies on the registry are indexed under Fibrocystic Breast Disease; 1 is open to participants now.

Browse Fibrocystic Breast Disease studies →

Lead sponsor

Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with clinical and ultrasonographic confirmation of breast fibrocystic disease.
  • Patients older than 20 years.
  • Female patients.
  • .

Exclusion criteria

Exclusion Criteria:

  • Presents of another disease not well controlled.
  • Pregnant women or lactating.
  • Patient which are receiving another products from other investigations trials.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    A

    Oncoxin, a nutritional supplement

    Dietary Supplement: Oncoxin

  • Placebo comparator
    B

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementOncoxin

    (caplets 300 mg), three oral caplets per day for 24 weeks

  • Dietary supplementPlacebo

    (caplets 300 mg), three oral caplets per day for 24 weeks

06

What researchers measure

Primary outcomes

  1. The ultrasonographic improvement at 24 weeks (end of the treatment)

    Time frame: 24 weeks

  2. Adverse effects at 24 weeks (end of the treatment)

    Time frame: 24 weeks

Secondary outcomes

  1. Lesion size according clinical measurement at 24 weeks (end of the treatment)

    Time frame: 24 weeks

  2. Pain according patient examination at 24 weeks (end of the treatment)

    Time frame: 24 weeks

07

Study locations

1 site
  • "Ramón González Coro" Gynecologic and Obstetric Hospital
    Havana, 10400, Cuba
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00967681
Lead sponsor
Catalysis SL
Responsible party
Sponsor
First posted
Aug 28, 2009
Start date
Sep 2009
Primary completion
Apr 2011
Completion
Apr 2011
Last update
May 4, 2012

Study contacts

Daisy Hernández, MD
principal investigator · Ramón González Coro Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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