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Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

Primary Purpose

Breast Fibrocystic Disease

Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Oncoxin
Placebo
Sponsored by
Catalysis SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Fibrocystic Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • "Ramón González Coro" Gynecologic and Obstetric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Oncoxin, a nutritional supplement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 27, 2009
Last Updated
May 2, 2012
Sponsor
Catalysis SL
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1. Study Identification

Unique Protocol Identification Number
NCT00967681
Brief Title
Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease
Official Title
Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Fibrocystic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Oncoxin, a nutritional supplement
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Oncoxin
Intervention Description
(caplets 300 mg), three oral caplets per day for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
(caplets 300 mg), three oral caplets per day for 24 weeks
Primary Outcome Measure Information:
Title
The ultrasonographic improvement at 24 weeks (end of the treatment)
Time Frame
24 weeks
Title
Adverse effects at 24 weeks (end of the treatment)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Lesion size according clinical measurement at 24 weeks (end of the treatment)
Time Frame
24 weeks
Title
Pain according patient examination at 24 weeks (end of the treatment)
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daisy Hernández, MD
Organizational Affiliation
Ramón González Coro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Ramón González Coro" Gynecologic and Obstetric Hospital
City
Havana
ZIP/Postal Code
10400
Country
Cuba

12. IPD Sharing Statement

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Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

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