Evaluation of Oncoxin-Viusid® in Cutaneous Melanoma

Cutaneous Melanoma, Stage III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541148
• Other study ID #: OOS-CANCER-2
• Status: Completed
• Phase: Phase 2
• Start date: September 16, 2014
• Est. completion date: April 13, 2018

Study information

• Verified date: May 2018
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 13, 2018
• Est. primary completion date: April 13, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Melanoma, Stage II
• Cutaneous Melanoma, Stage III
• Malignant Cutaneous Melanoma
• Melanoma

Intervention

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

Locations

Country	Name	City	State
Cuba	Manuel Fajardo Clinical Surgical University Hospital	La Habana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	Calculated according to the method of Kaplan Meyer	2 years
Primary	Disease free survival rate	Calculated according to the Kaplan Meyer method	2 years
Secondary	Temporary interruption of conventional treatment	Due to adverse events	2 years
Secondary	Presence of adverse events	Associated with conventional treatment	2 years
Secondary	Type of adverse events	According to severity and causality	2 years
Secondary	Quality of life	Quality of life questionnaire of the EORTC: QLQ30	2 years