Clinical trial NCT03541148: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous Melanoma, Stage II
Malignant Cutaneous Melanoma
Cutaneous Melanoma, Stage III
Keywords: Cutaneous malignant melanoma
Nutritional supplement
survival
Green tea
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Overall survival rate
timeFrame: 2 years
measure: Disease free survival rate
timeFrame: 2 years
Secondary outcomes:
measure: Temporary interruption of conventional treatment
timeFrame: 2 years
measure: Presence of adverse events
timeFrame: 2 years
measure: Type of adverse events
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: La Habana
country: Cuba
facility: Manuel Fajardo Clinical Surgical University Hospital
Study officials:
affiliation: Manuel Fajardo Clinical Surgical University Hospital
name: Olaine R. Gray Lovio, Dr.
role: PRINCIPAL_INVESTIGATOR
References: