Evaluation of Oncoxin-Viusid® in Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Dietary Supplement: Oncoxin-Viusid

• Registration Number: NCT03543670
• Lead Sponsor: Catalysis SL

Brief Summary

A not randomized clinical survey was done in 25 pacients with histological diagnosis confirmed of a prostatic adenocarcinoma and hardy in hormonotherapy at the Calixto Garcia Hospital in Habana (2016-2018).

Researches had as identifying goal the efecctiveness study of Oncoxin-Viusid® nutritional supplement as a support to convencional treatment. The patient were treated with habitual doses of Docetacel and 75 mg per day of supplement during and fiften day after the quimiotherapy. The rest of numbers and severety of adverse reactions were determined as well as its influences on life quality when this co-therapy is performed, the evaluation of progresion spare survival and the porcentage of recurrences.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-16
• Primary Completion: 2018-04-12
• Status Verified: 2018-05
• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-20
• Study First Posted: 2018-06-01
• Study Completion: 2018-12-30
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Masculine >18 years-old patients
• Performans status: Karnofsky ≥ 70 or (ECOG <2)
• Hormonal treatment alternatives 6 or 8 weeks before the inclusion ,with resistence to hormonal treatments
• Normal laboratory tests to onco-specific treatments.
• Ecocardiogram with a eyección fraction > 60 %, in patients with history of cardiovascular deseases.
• Patients with life expectative more than 6 months.

Exclusion Criteria

• Patients who are receiving another onco-specific product in research.
• Patients with known hypersensitivity to anthracyclines and / or mitoxantrone
• Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health and life at risk during the study or your participation in the trial.
• Patients with cerebral metastases.
• Patients with HIV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oncoxin-Viusid	Oncoxin-Viusid	-

Primary Outcome Measures

Name	Time	Method
Quality of Life	12 months	General quality of life (EORTC QLQ C30 questionnaire and specific for prostate cancer EORTC QLQ - PR25)
Adverse events	12 months	Toxicity (hematological, hemochemistry, clinical response) stablished by WHO

Secondary Outcome Measures

Name	Time	Method
Overal survival	12 months	Global Survival Rate (GSR)
Overal recurrences	12 months	Progression-free survival - PFS

Trial Locations

Locations (1)

General Calixto García University Hospital; 🇨🇺 La Habana, Cuba