Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00967681
First received: August 27, 2009
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Breast Fibrocystic Disease
Dietary Supplement: Oncoxin
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • The ultrasonographic improvement at 24 weeks (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Adverse effects at 24 weeks (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lesion size according clinical measurement at 24 weeks (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Pain according patient examination at 24 weeks (end of the treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT00967681     History of Changes
Other Study ID Numbers: CAT-0901-CU
Study First Received: August 27, 2009
Last Updated: May 2, 2012
Health Authority: Cuba: Scientific and Ethics Committee

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

ClinicalTrials.gov processed this record on April 17, 2014