"Combined Oncoxin-Viusid® Treatment With Radiotherapy and Chemotherapy in Patients With Head and Neck Cancer. Phase II, Randomized and Double-blind Study"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improve the quality of life of patients during radiotherapy
研究概览
简要总结
Nutritional supplements containing antioxidants seem to decrease toxicity associated with Radiotherapy (RT) and Chemotherapy (CT) in patients with malignant head and neck tumors. Oncoxin-Viusid® (OV) is a nutritional supplement with antioxidant, immunomodulator and antitumor effects.
详细描述
Objective
To assess the efficacy and safety of OV in patients with head and neck tumors during treatment with radio-chemotherapy.
Materials and Methods
Patients diagnosed with Head and Neck Carcinoma, and indicated to follow a radiotherapy treatment concurrent with Radiosensitizing Chemotherapy, were included in a phase II, randomized, prospective, controlled and double-blind study in two treatment arms: RT + CT + Placebo (n = 30) and RT + CT + OV (n = 30) during one year in a tertiary center (INOR), with the aim of evaluating the reduction of toxicities of RT-CT and improve the quality of life of patients during these oncospecific treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes
- •over 18 years of age
- •With histological diagnosis of carcinoma of the head and neck
- •Regardless of the variety or degree of histological differentiation and clinical stage
- •Tributaries of concomitant treatment with ionizing radiation and radiosensitizing chemotherapy with intercurrent diseases compensated and index of Karnofsky > 59
- •Acceptable hematological parameters
- •Women not pregnant or lactating
- •Who authorized their inclusion in the investigation, through their informed consent.
排除标准
- •Patients with a second concomitant primary tumor and / or contraindication to platinum chemotherapy
- •Patients who are under another research protocol or who have decompensated psychiatric disorders.
结局指标
主要结局
Improve the quality of life of patients during radiotherapy
时间窗: 4 months
Index of Karnofsky
Decrease the degrees of toxicities of Radiotherapy and Chemotherapy
时间窗: 4 months
Tumor biopsy
次要结局
- Duration of the therapeutic range of radiotherapy(4 months)