Clinical Trial: Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease

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.

Detailed Summary:
Sponsor: Catalysis SL

Current 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Catalysis SL

Dates:
Date Received: August 27, 2009
Date Started: September 2009
Date Completion:
Last Updated: May 2, 2012
Last Verified: May 2012