Evaluation of Oncoxin-Viusid® in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543670
• Other study ID #: OOS-CANCER-4
• Status: Completed
• Phase: Phase 2
• Start date: September 16, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: May 2018
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 30, 2018
• Est. primary completion date: April 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• Oncoxin-Viusid
Support treatment with Oncoxin-Viusid (75mL/day) during chemotherapy/Radiotherapy until two weeks after (a total of 8 months).

Locations

Country	Name	City	State
Cuba	General Calixto García University Hospital	La Habana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	General quality of life (EORTC QLQ C30 questionnaire and specific for prostate cancer EORTC QLQ - PR25)	12 months
Primary	Adverse events	Toxicity (hematological, hemochemistry, clinical response) stablished by WHO	12 months
Secondary	Overal survival	Global Survival Rate (GSR)	12 months
Secondary	Overal recurrences	Progression-free survival - PFS	12 months