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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncoxin-Viusid | Experimental | Nutritional supplement Oncoxin-Viusid 25 mL in oral solution twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncoxin-Viusid | Dietary Supplement | Oncoxin-Viusid supplement before/during/after standard surgical and adjuvant treatment or chemotherapy. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Temporary interruption of conventional treatment | Due to adverse events | 2 years |
| Presence of adverse events | Associated with conventional treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olaine R. Gray Lovio, Dr. | Manuel Fajardo Clinical Surgical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manuel Fajardo Clinical Surgical University Hospital | La Habana | 10600 | Cuba |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D000096142 | Melanoma, Cutaneous Malignant |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |