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Evaluation of Oncoxin-Viusid® in Cutaneous Melanoma

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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


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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541148


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

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT03541148     History of Changes
Other Study ID Numbers: OOS-CANCER-2
First Posted: May 30, 2018    Key Record Dates
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
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas