Prostate CancerPhase 2NCT03543670
Evaluation of Oncoxin-Viusid® in Prostate Cancer
A Phase 2 study testing Oncoxin-Viusid in people with Prostate Cancer, run by Catalysis SL at 1 site in Cuba.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Oncoxin-Viusid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCuba
- Study dates
- 16 Sep 2017to 30 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Oncoxin-Viusin® Nutritional Supplement Related With the Onco-specific Treatments in Prostate Cancer Patients
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.
- Conditions
- Prostate Cancer
- Being tested
- Oncoxin-Viusid
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncoxin-ViusidDietary supplement
Support treatment with Oncoxin-Viusid (75mL/day) during chemotherapy/Radiotherapy until two weeks after (a total of 8 months).
| Study group | Role | What they receive |
|---|---|---|
| Oncoxin-Viusid | Experimental | Not described Receives: Dietary Supplement: Oncoxin-Viusid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
General quality of life (EORTC QLQ C30 questionnaire and specific for prostate cancer EORTC QLQ - PR25)
Measured: 12 months
Adverse events
Toxicity (hematological, hemochemistry, clinical response) stablished by WHO
Measured: 12 months
Secondary outcomes (2)
Overal survival
Global Survival Rate (GSR)
Measured: 12 months
Overal recurrences
Progression-free survival - PFS
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start16 Sep 2017
- Primary completion12 Apr 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mercedes I. Fundora, Dr., Principal investigator, General Calixto García University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543670
- Sponsor's protocol ID
- OOS-CANCER-4
- Status last verified
- May 2018
- First submitted
- 3 May 2018
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33235733
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oncoxin-Viusin® Nutritional Supplement Related With the Onco-specific Treatments in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03543670
- Acronym / sponsor ID
- OOS-CANCER-4
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2017 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncoxin-Viusid | Experimental | Dietary Supplement: Oncoxin-Viusid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncoxin-ViusidSupport treatment with Oncoxin-Viusid (75mL/day) during chemotherapy/Radiotherapy until two weeks after (a total of 8 months). | Dietary supplement | Oncoxin-Viusid |
Primary outcome
Quality of Life
Time frame: 12 months
General quality of life (EORTC QLQ C30 questionnaire and specific for prostate cancer EORTC QLQ - PR25)
Adverse events
Time frame: 12 months
Toxicity (hematological, hemochemistry, clinical response) stablished by WHO
2 secondary outcomes
Overal survival
Time frame: 12 months
Overal recurrences
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Derived from this study: PubMed 33235733Fundora 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mercedes I. Fundora, Dr. principal investigator
General Calixto García University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oncoxin-Viusid in people with Prostate Cancer, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.