Clinical trial NCT03543670: Evaluation of Oncoxin-Viusid® in Prostate Cancer
Official title: Efficacy of Oncoxin-Viusin® Nutritional Supplement Related With the Onco-specific Treatments in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-06-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Overal survival
timeFrame: 12 months
measure: Overal recurrences
timeFrame: 12 months
Other outcomes:
Locations:
city: La Habana
country: Cuba
facility: General Calixto García University Hospital
Study officials:
affiliation: General Calixto García University Hospital
name: Mercedes I. Fundora, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fundora Ramos MI, Maden LB, Casanova FO, Cruz FH, Reyes CS, Gato AH, Lyncon IB, Gonzalez EV, Morales KP, Lence JJ, Sanz E. Oncoxin-Viusid(R) may improve quality of life and survival in patients with hormone-refractory prostate cancer undergoing onco-specific treatments. Mol Clin Oncol. 2021 Jan;14(1):5. doi: 10.3892/mco.2020.2167. Epub 2020 Nov 5.