Evaluation of Oncoxin-Viusid® in Cutaneous Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cutaneous Melanoma, Stage II, Malignant Cutaneous Melanoma, Cutaneous Melanoma, Stage III

Intervention / Treatment
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* Dietary Supplement: Oncoxin-Viusid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cutaneous malignant melanoma, Nutritional supplement, survival, Green tea