NCT03543670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

May 3, 2018

Last Update Submit

May 21, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Quality of Life

    General quality of life (EORTC QLQ C30 questionnaire and specific for prostate cancer EORTC QLQ - PR25)

    12 months

  • Adverse events

    Toxicity (hematological, hemochemistry, clinical response) stablished by WHO

    12 months

Secondary Outcomes (2)

  • Overal survival

    12 months

  • Overal recurrences

    12 months

Study Arms (1)

Oncoxin-Viusid

EXPERIMENTAL
Dietary Supplement: Oncoxin-Viusid

Interventions

Oncoxin-ViusidDIETARY_SUPPLEMENT

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

Oncoxin-Viusid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Masculine \>18 years-old patients
  • Performans status: Karnofsky ≥ 70 or (ECOG \<2)
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Calixto García University Hospital

La Habana, 10400, Cuba

Location

Related Publications (1)

  • 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.

    PMID: 33235733DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Mercedes I. Fundora, Dr.

    General Calixto García University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

June 1, 2018

Study Start

September 16, 2017

Primary Completion

April 12, 2018

Study Completion

December 30, 2018

Last Updated

May 22, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

CU(1)