Evaluation of the Nutritional Supplement Oncoxin-Viusid® in the Treatment of 20 Patients With Cutaneous Melanoma in Stage IIB-IIIA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Overall survival rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 ≥
- •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.
排除标准
- •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.
结局指标
主要结局
Overall survival rate
时间窗: 2 years
Calculated according to the method of Kaplan Meyer
Disease free survival rate
时间窗: 2 years
Calculated according to the Kaplan Meyer method
次要结局
- Temporary interruption of conventional treatment(2 years)
- Presence of adverse events(2 years)
- Type of adverse events(2 years)
- Quality of life(2 years)