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Evaluation of Oncoxin-Viusid® in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03543670
Recruitment Status : Active, not recruiting
First Posted : June 1, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: Oncoxin-Viusid Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy of Oncoxin-Viusin® Nutritional Supplement Related With the Onco-specific Treatments in Prostate Cancer Patients
Actual Study Start Date : September 16, 2017
Actual Primary Completion Date : April 12, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 12 months ]
    General quality of life (EORTC QLQ C30 questionnaire and specific for prostate cancer EORTC QLQ - PR25)

  2. Adverse events [ Time Frame: 12 months ]
    Toxicity (hematological, hemochemistry, clinical response) stablished by WHO


Secondary Outcome Measures :
  1. Overal survival [ Time Frame: 12 months ]
    Global Survival Rate (GSR)

  2. Overal recurrences [ Time Frame: 12 months ]
    Progression-free survival - PFS



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543670


Locations
Cuba
General Calixto García University Hospital
La Habana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Mercedes I. Fundora, Dr. General Calixto García University Hospital

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT03543670     History of Changes
Other Study ID Numbers: OOS-CANCER-4
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases