NCT03541148

Brief Summary

Malignant melanoma, responsible for 75% of deaths from skin cancer. Current therapeutic options have poor response, many adverse events and high costs. For this reason, a study with nutritional supplement Oncoxin-Viusid was carried out. According to previous studies, it has an antitumor, immunomodulatory effect and to potentiate the antiproliferative effect of standard chemotherapeutic agents in different locations and stages of cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2014

Typical duration for phase_2

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, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

May 3, 2018

Last Update Submit

May 17, 2018

Conditions

Cutaneous Melanoma, Stage IIMalignant Cutaneous MelanomaCutaneous Melanoma, Stage III

Keywords

Cutaneous malignant melanomaNutritional supplementsurvivalGreen tea

Outcome Measures

Primary Outcomes (2)

  • Overall survival rate

    Calculated according to the method of Kaplan Meyer

    2 years

  • Disease free survival rate

    Calculated according to the Kaplan Meyer method

    2 years

Secondary Outcomes (4)

  • Temporary interruption of conventional treatment

    2 years

  • Presence of adverse events

    2 years

  • Type of adverse events

    2 years

  • Quality of life

    2 years

Study Arms (1)

Oncoxin-Viusid

EXPERIMENTAL

Nutritional supplement Oncoxin-Viusid 25 mL in oral solution twice a day

Dietary Supplement: Oncoxin-Viusid

Interventions

Oncoxin-ViusidDIETARY_SUPPLEMENT

Oncoxin-Viusid supplement before/during/after standard surgical and adjuvant treatment or chemotherapy.

Oncoxin-Viusid

Eligibility Criteria

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

You may qualify if:

  • Patients with histological diagnosis of Malignant Cutaneous Melanoma in stage IIB-IIC-IIIA
  • Subjects of 18 years and over of both sexes.
  • General health status according to the Karnofsky Index ≥ 70.
  • Laboratory parameters within the normal limits defined as: Hematopoietic: Hemoglobin ≥ 9 g / L, Total Leukocytes ≥ 3 x 109 cells / L, Neutrophils ≥ 1.5 x 109 cells / L, Platelets ≥ 100 x 109 / L Hepatic: Liver function within 2.5 times upper normal limit and without liver disease demonstrated by TGP, OGT and alkaline phosphatase.
  • Patients who express written voluntariness to enter the study with their signature of the informed consent document.
  • Women of childbearing age should have a negative pregnancy test and use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.

You may not qualify if:

  • Pregnancy or lactation.
  • Patients with a second concomitant tumor.
  • Present an associated chronic disease in the decompensation phase (heart disease, diabetes, hypertension).
  • History of hypersensitivity to another similar product.
  • Severe acute allergic states.
  • Severe septic processes.
  • Non-operated patients, in whom the surgery was contraindicated.
  • Patients at potential risk of not completing the study (those who will travel during the period of the investigation or distance in their residence, outside the city).
  • Subjects who are participating in another clinical trial.
  • Patients with cognitive disorders or a mental disorder that hinders their follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manuel Fajardo Clinical Surgical University Hospital

La Habana, 10600, Cuba

Location

MeSH Terms

Conditions

MelanomaMelanoma, Cutaneous Malignant

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Olaine R. Gray Lovio, Dr.

    Manuel Fajardo Clinical Surgical 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

May 30, 2018

Study Start

September 16, 2014

Primary Completion

April 13, 2016

Study Completion

April 13, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

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

Locations

CU(1)