Exploratory Study to Evaluate the Effect and Safety of the Use of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours
试验速览
- 阶段
- 不适用
- 发起方
- Catalysis SL
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
Exploratory study to evaluate the effect and safety of the use of Ocoxin® oral solution on the quality of life of paediatric patients with advanced stage solid tumours.
详细描述
This is a prospective, open-label, single-centre, exploratory study in paediatric patients with advanced stage solid tumours receiving oncospecific therapy.
Ocoxin®: The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Catalysis S.L. of Spain. It comes in the form of 30 ml single-dose vials.
Forty paediatric patients will be included, distributed as follows: Hodgkin's lymphoma (10), Central Nervous System tumours (10), Sarcoma of any type (10) or Germinal Tumours (10).
Patients will receive one vial of Ocoxin® daily from the start of oncospecific therapy until two weeks after the end of therapy.
Prior to the start of treatment and before each cycle of QT, a haemogram and haemochemistry including albumin, total proteins, transaminases (TGO, TGP) will be performed. Physical examinations will be performed, and the patient's vital signs and body weight will be evaluated.
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
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of either sex in the paediatric age group, between 7 and 18 years of age.
- •Father, mother or legal guardian who consents in writing to the minor's participation in the study. Written consent of the minor for ages 12 to 18 years. Verbal consent of the minor for ages 7 to 11 years.
- •Histologically confirmed diagnosis of solid tumour of any location, in advanced stage, with criteria to receive oncospecific therapy.
- •Patients with haematological parameters within normal figures that allow them to receive oncospecific therapy, according to the management protocols for each of the diseases.
排除标准
- •Pregnancy or breast-feeding (if less than 3 months have elapsed since delivery, abortion, or breast-feeding prior to the start of treatment).
- •Hypersensitivity to any component of the product under study (Ocoxin®).
- •Any disease or condition that could interfere with the interpretation of the results.
研究组 & 干预措施
Ocoxin Oral Solution
Patients will receive one vial of Ocoxin® daily from the start of oncospecific therapy until two weeks after the end of therapy.
干预措施: Ocoxin Oral solution (Dietary Supplement)
结局指标
主要结局
Quality of Life
时间窗: 7 months
Qualitative and quantitative data collection. To assess the effect of Ocoxin® on the quality of life of paediatric patients with advanced solid tumours by the Paediatric Quality of Life Questionnaire (PedsQLTm, version 4.0. Spanish). The questionnaire will be administered to the parent or guardian prior to the start of treatment, at month 3 and at the end of treatment with Ocoxin®. In the case of longer treatment regimens, intermediate quality of life measurements may be taken after the three-month treatment and before the end of treatment.
次要结局
- Nutritional Status(7 months)
- Metabolic Status(7 months)
- Response to oncospecific treatment(7 months)
- Degree of toxicity related to oncospecific treatment(7 months)
- Presence of Adverse Events (AE)(7 months)
- Physical Status(7 months)