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OpenTrials
Completed

NCT Number: NCT03543670

Evaluation of Oncoxin-Viusid® in Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

General Calixto García University Hospital

La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oncoxin-Viusid

Dietary Supplement

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

Primary outcomes

  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 outcomes

  1. Overal survival

    Time frame: 12 months

    Global Survival Rate (GSR)

  2. Overal recurrences

    Time frame: 12 months

    Progression-free survival - PFS

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2018
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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