A Pilot, Randomized, Double Blind, Placebo Controlled Study to Evaluate an Immune System Modulator Nutritional Supplement for the Prevention of Infections in Cancer Patients Receiving Oncologic Treatment During the COVID-19 Pandemia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Number of infectious events
研究概览
简要总结
This study is designed to assess the safety and efficacy of Rosmalip® nutritional supplement compared to placebo in subjects with solid cancer for the prevention of infections including COVID-19.
详细描述
Cancer patients undergoing oncologic treatments frequently have comorbidities and suffer immunosuppresion, toxicities and exposure to nosocomial pathogens. As a result, they are at increased risk of infections, including COVID-19. It is of utmost importance to find therapies that can prevent infections with as less toxicity as possible. Rosmalip® is a nutritional supplement developed as a molecular nutrition, composed of a rosemary supercritical extract at concentrations approved by EFSA -with in vitro and in vivo antitumor effects that are independent of its antioxidant and anti-inflammatory properties- in a lipidic vehicle that has shown in preclinical and clinical studies to potentiate innate immunity without apparent toxicity. Being a product of easy synthesis its effects on immunity, inflammation and cancer, could be of interest to prevent and ameliorate infections, including COVID-19.
In this pilot study it is hypothesized that Rosmalip® could help to prevent or ameliorate infections, including COVID-19, in oncologic patients under active treatment. Secondarily, it is also hypothesized to have metabolic beneficial effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a solid cancer under active Anticancer Treatment (including Chemotherapy, Immunotherapy, Hormone Therapy, Targeted Therapy)
- •Informed consent signature
排除标准
- •Allergies to fish
- •Vitamin, Antioxidants consumers and who would no accept to stop taking them 1 week before and during the study
- •Disphagia
- •Bilirrubin higher than 1.5 Upper Normal Limit (UNL)/ Creatinin > 1.5 UNL
- •Severe organic dysfunction
- •Cardiac dysfunction
- •Cholangitis/ Biliary tract obstruction
- •Immunodeficiency or Immflamatory disease (HIV, Inflammatory Bowel Disease, Collagenosis)
- •Dementia or Psychiatric severe disease
- •Pregnancy or Breastfeeding
- •Previous diseases that interfere lipid carrier absorption
结局指标
主要结局
Number of infectious events
时间窗: 6 months
Number of infectious events according to International Sepsis Forum Consensus
次要结局
- Evolution of Quality of life(6 months)
- Changes in C-reactive protein(6 months)
- Number of SARSCoV2 infections(6 months)
- Changes in NLR (neutrophils to lymphocytes ratio).(6 months)
- Changes in ferritin(6 months)
- Changes in transferrin(6 months)
- Changes in number of peripheral blood mononuclear cells(6 months)
- Changes in number of CD4 and CD8 lymphocyte populations(6 months)
研究者
Enrique Casado Sáenz
Head of Oncology
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares