Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Breast Fibrocystic Disease

Treatments: Dietary Supplement: Oncoxin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00967681

CAT-0901-CU

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Oncoxin, a nutritional supplement

Treatment:

Dietary Supplement: Oncoxin

B

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo