Evaluation of Oncoxin-Viusid® in Cutaneous Melanoma

Evaluation of the Nutritional Supplement Oncoxin-Viusid® in the Treatment of 20 Patients With Cutaneous Melanoma in Stage IIB-IIIA

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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Melanoma, Stage II; Cutaneous Melanoma, Stage III; Malignant Cutaneous Melanoma
• Intervention / Treatment: Dietary supplement: Oncoxin-Viusid

Detailed Description

Performed at Manuel Fajardo Surgical Clinical University Hospital in Havana, Cuba from September 2014 to April 2018, following a proof of concept open label study, with no control group in 20 patients diagnosed histologically in Fajardo Hospital or Oncology Institute, as Melanoma, primary cutaneous stage IIB-IIIA. All received conventional surgical treatment and oral Oncoxin-Viusid (25 ml 2 times a day for one year), where it was also indicated adjuvant treatment or chemotherapy. All were evaluated monthly the first year and semesterly the second year. Complying with the provisions of the Helsinki Act.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Cuba
  • La Habana, Cuba, 10600
    • Manuel Fajardo Clinical Surgical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oncoxin-Viusid; Nutritional supplement Oncoxin-Viusid 25 mL in oral solution twice a day	Dietary supplement: Oncoxin-Viusid; Oncoxin-Viusid supplement before/during/after standard surgical and adjuvant treatment or chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporary interruption of conventional treatment	Due to adverse events	2 years
Presence of adverse events	Associated with conventional treatment	2 years
Type of adverse events	According to severity and causality	2 years
Quality of life	Quality of life questionnaire of the EORTC: QLQ30	2 years

Collaborators and Investigators

• Sponsor: Catalysis SL
• Investigators: Principal Investigator: Olaine R. Gray Lovio, Dr., Manuel Fajardo Clinical Surgical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2014
• Primary Completion (Actual): April 13, 2016
• Study Completion (Actual): April 13, 2018

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: survival; Nutritional supplement; Green tea; Cutaneous malignant melanoma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Skin Neoplasms
• Other Study ID Numbers: OOS-CANCER-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No