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Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00967681
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Breast Fibrocystic Disease Dietary Supplement: Oncoxin Dietary Supplement: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease
Study Start Date : September 2009
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
Oncoxin, a nutritional supplement
Dietary Supplement: Oncoxin
(caplets 300 mg), three oral caplets per day for 24 weeks
Placebo Comparator: B Dietary Supplement: Placebo
(caplets 300 mg), three oral caplets per day for 24 weeks


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967681


Locations
Cuba
"Ramón González Coro" Gynecologic and Obstetric Hospital
Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Daisy Hernández, MD Ramón González Coro Hospital
More Information

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT00967681     History of Changes
Other Study ID Numbers: CAT-0901-CU
First Posted: August 28, 2009    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrocystic Breast Disease
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Breast Diseases
Skin Diseases