Evaluation of Oncoxin-Viusid® in Cutaneous Melanoma

• ClinicalTrials.gov Identifier: NCT03541148
• Recruitment Status: Completed
• First Posted: May 30, 2018
• Last Update Posted: May 30, 2018
• Sponsor: Catalysis SL
• Information provided by (Responsible Party): Catalysis SL

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cutaneous Melanoma, Stage II; Malignant Cutaneous Melanoma; Cutaneous Melanoma, Stage III	Dietary Supplement: Oncoxin-Viusid	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of the Nutritional Supplement Oncoxin-Viusid® in the Treatment of 20 Patients With Cutaneous Melanoma in Stage IIB-IIIA
• Actual Study Start Date: September 16, 2014
• Actual Primary Completion Date: April 13, 2016
• Actual Study Completion Date: April 13, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Overall survival rate [ Time Frame: 2 years ]
   Calculated according to the method of Kaplan Meyer
2. Disease free survival rate [ Time Frame: 2 years ]
   Calculated according to the Kaplan Meyer method

Secondary Outcome Measures :

1. Temporary interruption of conventional treatment [ Time Frame: 2 years ]
   Due to adverse events
2. Presence of adverse events [ Time Frame: 2 years ]
   Associated with conventional treatment
3. Type of adverse events [ Time Frame: 2 years ]
   According to severity and causality
4. Quality of life [ Time Frame: 2 years ]
   Quality of life questionnaire of the EORTC: QLQ30

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Cuba

Manuel Fajardo Clinical Surgical University Hospital

La Habana, Cuba, 10600

Sponsors and Collaborators

Catalysis SL

Investigators

• Principal Investigator: Olaine R. Gray Lovio, Dr.; Manuel Fajardo Clinical Surgical University Hospital

More Information

• Responsible Party: Catalysis SL
• ClinicalTrials.gov Identifier: NCT03541148
• Other Study ID Numbers: OOS-CANCER-2
• First Posted: May 30, 2018
• Last Update Posted: May 30, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catalysis SL:

Cutaneous malignant melanoma; Nutritional supplement; survival; Green tea

Additional relevant MeSH terms:

Melanoma; Skin Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases