NCT00967681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

1.6 years

First QC Date

August 27, 2009

Last Update Submit

May 2, 2012

Conditions

Breast Fibrocystic Disease

Outcome Measures

Primary Outcomes (2)

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

    24 weeks

  • Adverse effects at 24 weeks (end of the treatment)

    24 weeks

Secondary Outcomes (2)

  • 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

Study Arms (2)

A

EXPERIMENTAL

Oncoxin, a nutritional supplement

Dietary Supplement: Oncoxin

B

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

OncoxinDIETARY_SUPPLEMENT

(caplets 300 mg), three oral caplets per day for 24 weeks

A
PlaceboDIETARY_SUPPLEMENT

(caplets 300 mg), three oral caplets per day for 24 weeks

B

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinical and ultrasonographic confirmation of breast fibrocystic disease.
  • Patients older than 20 years.
  • Female patients.
  • Informed consent.

You may not qualify if:

  • Presents of another disease not well controlled.
  • Pregnant women or lactating.
  • Patient which are receiving another products from other investigations trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Ramón González Coro" Gynecologic and Obstetric Hospital

Havana, La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Fibrocystic Breast Disease

Condition Hierarchy (Ancestors)

Breast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Daisy Hernández, MD

    Ramón González Coro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2009

First Posted

August 28, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 4, 2012

Record last verified: 2012-05

Locations

CU(1)