Evaluation of Oncoxin-Viusid® in Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Oncoxin-Viusin® Nutritional Supplement Related With the Onco-specific Treatments in Prostate Cancer Patients

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: Oncoxin-Viusid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oncoxin-Viusid<br> | Dietary Supplement: Oncoxin-Viusid<br>* Support treatment with Oncoxin-Viusid (75mL/day) during chemotherapy/Radiotherapy until two weeks after (a total of 8 months).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overal survival | Global Survival Rate (GSR) | 12 months | 
| Overal recurrences | Progression-free survival - PFS | 12 months |