Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

Phase 3

Completed

• Conditions: Breast Fibrocystic Disease
• Interventions: Dietary Supplement: Oncoxin; Dietary Supplement: Placebo

• Registration Number: NCT00967681
• Lead Sponsor: Catalysis SL

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 Description

Not available

Study Timeline

• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-28
• Study Start: 2009-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Oncoxin	Oncoxin, a nutritional supplement
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
The ultrasonographic improvement at 24 weeks (end of the treatment)	24 weeks
Adverse effects at 24 weeks (end of the treatment)	24 weeks

Secondary Outcome Measures

Name	Time	Method
Lesion size according clinical measurement at 24 weeks (end of the treatment)	24 weeks
Pain according patient examination at 24 weeks (end of the treatment)	24 weeks

Trial Locations

Locations (1)

"Ramón González Coro" Gynecologic and Obstetric Hospital; 🇨🇺 Havana, Cuba