Back to resultsEvaluation of Oncoxin-Viusid® in Cutaneous Melanoma
Primary Purpose
Cutaneous Melanoma, Stage II, Malignant Cutaneous Melanoma, Cutaneous Melanoma, Stage III
Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Oncoxin-Viusid
Sponsored by
About this trial
This is an interventional supportive care trial for Cutaneous Melanoma, Stage II focused on measuring Cutaneous malignant melanoma, Nutritional supplement, survival, Green tea
Eligibility 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.
Sites / Locations
- Manuel Fajardo Clinical Surgical University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oncoxin-Viusid
Arm Description
Nutritional supplement Oncoxin-Viusid 25 mL in oral solution twice a day
Outcomes
Primary Outcome Measures
Overall survival rate
Calculated according to the method of Kaplan Meyer
Disease free survival rate
Calculated according to the Kaplan Meyer method
Secondary Outcome Measures
Temporary interruption of conventional treatment
Due to adverse events
Presence of adverse events
Associated with conventional treatment
Type of adverse events
According to severity and causality
Quality of life
Quality of life questionnaire of the EORTC: QLQ30
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03541148
Brief Title
Evaluation of Oncoxin-Viusid® in Cutaneous Melanoma
Official Title
Evaluation of the Nutritional Supplement Oncoxin-Viusid® in the Treatment of 20 Patients With Cutaneous Melanoma in Stage IIB-IIIA
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2014 (Actual)
Primary Completion Date
April 13, 2016 (Actual)
Study Completion Date
April 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Melanoma, Stage II, Malignant Cutaneous Melanoma, Cutaneous Melanoma, Stage III
Keywords
Cutaneous malignant melanoma, Nutritional supplement, survival, Green tea
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oncoxin-Viusid
Arm Type
Experimental
Arm Description
Nutritional supplement Oncoxin-Viusid 25 mL in oral solution twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Oncoxin-Viusid
Intervention Description
Oncoxin-Viusid supplement before/during/after standard surgical and adjuvant treatment or chemotherapy.
Primary Outcome Measure Information:
Title
Overall survival rate
Description
Calculated according to the method of Kaplan Meyer
Time Frame
2 years
Title
Disease free survival rate
Description
Calculated according to the Kaplan Meyer method
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Temporary interruption of conventional treatment
Description
Due to adverse events
Time Frame
2 years
Title
Presence of adverse events
Description
Associated with conventional treatment
Time Frame
2 years
Title
Type of adverse events
Description
According to severity and causality
Time Frame
2 years
Title
Quality of life
Description
Quality of life questionnaire of the EORTC: QLQ30
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olaine R. Gray Lovio, Dr.
Organizational Affiliation
Manuel Fajardo Clinical Surgical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manuel Fajardo Clinical Surgical University Hospital
City
La Habana
ZIP/Postal Code
10600
Country
Cuba
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of Oncoxin-Viusid® in Cutaneous Melanoma
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