Back to resultsEvaluation of Oncoxin-Viusid® in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Oncoxin-Viusid
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer
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.
Sites / Locations
- General Calixto García University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oncoxin-Viusid
Arm Description
Outcomes
Primary Outcome Measures
Quality of Life
General quality of life (EORTC QLQ C30 questionnaire and specific for prostate cancer EORTC QLQ - PR25)
Adverse events
Toxicity (hematological, hemochemistry, clinical response) stablished by WHO
Secondary Outcome Measures
Overal survival
Global Survival Rate (GSR)
Overal recurrences
Progression-free survival - PFS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03543670
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2017 (Actual)
Primary Completion Date
April 12, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oncoxin-Viusid
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Oncoxin-Viusid
Intervention Description
Support treatment with Oncoxin-Viusid (75mL/day) during chemotherapy/Radiotherapy until two weeks after (a total of 8 months).
Primary Outcome Measure Information:
Title
Quality of Life
Description
General quality of life (EORTC QLQ C30 questionnaire and specific for prostate cancer EORTC QLQ - PR25)
Time Frame
12 months
Title
Adverse events
Description
Toxicity (hematological, hemochemistry, clinical response) stablished by WHO
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overal survival
Description
Global Survival Rate (GSR)
Time Frame
12 months
Title
Overal recurrences
Description
Progression-free survival - PFS
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercedes I. Fundora, Dr.
Organizational Affiliation
General Calixto García University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Calixto García University Hospital
City
La Habana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
33235733
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.
Results Reference
derived
Learn more about this trial
Evaluation of Oncoxin-Viusid® in Prostate Cancer
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