Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

May 2, 2012 updated by: Catalysis SL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Presents of another disease not well controlled.
  • Pregnant women or lactating.
  • Patient which are receiving another products from other investigations trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: B
Dietary supplement: Placebo
(caplets 300 mg), three oral caplets per day for 24 weeks
EXPERIMENTAL: A
Oncoxin, a nutritional supplement
Dietary supplement: Oncoxin
(caplets 300 mg), three oral caplets per day for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The ultrasonographic improvement at 24 weeks (end of the treatment)
Time Frame: 24 weeks
24 weeks
Adverse effects at 24 weeks (end of the treatment)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Lesion size according clinical measurement at 24 weeks (end of the treatment)
Time Frame: 24 weeks
24 weeks
Pain according patient examination at 24 weeks (end of the treatment)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Daisy Hernández, MD, Ramón González Coro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

August 27, 2009

First Submitted That Met QC Criteria

August 27, 2009

First Posted (ESTIMATE)

August 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 4, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0901-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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