Evaluation of Oncoxin-Viusid® in Prostate Cancer

Catalysis SL

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Dietary Supplement: Oncoxin-Viusid

Study type

Interventional

Funder types

Industry

Identifiers

NCT03543670

OOS-CANCER-4

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.