NCT05606848招募中不适用
Efficacy and Safety of Fresubin Support Drink for Enteral Nutrition Support in Perioperative Patients With Gastrointestinal Cancer: A Prospective, Randomized, Open-Label, Active-Controlled Multi-Center Clinical Trial
Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd15 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2022年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 15
- 主要终点
- Change in serum prealbumin
研究概览
简要总结
This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. Aim of the study is to evaluate the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal cancer undergoing surgical resection during the perioperative period.
详细描述
This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. The IMP includes study product and control product. The study product will be Fresubin Support Drink (FSMP), the control product will be Enteral Nutrition Emulsion(TPF-T) . Not exceed 350 patients will be randomly assigned to the Fresubin Support Drink (FSMP) group or Enteral Nutrition Emulsion(TPF-T) group at a ratio of 1:1.
Prealbumin, albumin, C-reactive protein (CRP), immunology parameters, vital signs, nutrition and safety-related laboratory parameters, compliance, and Adverse Events (AEs) will be evaluated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreed to participate in the study with signed ICF;
- •Age 18-75 years;
- •Patient has gastrointestinal cancer confirmed by histological or imagological method and scheduled for resection via open or laparoscopic surgery;
- •Radiotherapy and/or Chemotherapy was not performed within 2 weeks before screening;
- •Hemoglobin ≥ 90 g/L
- •Albumin ≥ 2.5 g/dL
- •BMI ≥18.5 and ≤29 kg/m2;
- •ECOG Performance status 0-2 preoperatively;
- •Expected survival time >6 months.
排除标准
- •Contraindication or intolerance against EN, e.g., acute gastrointestinal bleeding, ileus (Grade≥3 NCI-CTCAE v 5.0);
- •Any congenital defect of amino acid or carbohydrate metabolism, such as phenylalaninemia, galactosaemia;
- •Conditions requiring emergency surgery;
- •Conditions other than cancer and surgery that can be associated with loss of body weight e.g. serious active clinical infections (> Grade 2, NCI-CTCAE 5.0), including active tuberculosis, or self-reported HIV infection or active hepatitis B or C;
- •Known treatment refractory metabolic disease (e.g., poorly-controlled diabetes mellitus or fasting blood glucose≥ 10mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis);
- •Cardiac dysfunction (New York Heart Association Functional Class > III);
- •Severe hepatic dysfunction associated with significant increase of AST or ALT > 5 ULN or bilirubin > 3 ULN;
- •Severe renal dysfunction associated with serum creatinine concentration > 1.5 ULN and/or required dialysis;
- •Active treatment refractory bleeding;
- •Other malignancies in the last 3 years (except for successfully treated in situ basocellular skin or in situ cervical uterine tumours);
- •Known disease that could seriously affect the digestion and absorption of the IMPs;
- •History of drug or alcohol abuse within 6 months prior to screening;
- •Current use of medication or nutritional supplements containing more than 500 mg of EPA+DHA/day or fish oil capsules/ supplements containing more than 500 mg EPA + DHA/day at screening;
- •Current use of muscle growth supporting substances (e.g., anabolics) at screening;
- •Planned chemotherapy, radiotherapy or immunotherapy during the first 12 days following the surgical tumor resection;
- •Transfusion of blood products within 1 week before screening;
- •Known allergy to contents of the study product or control product;
- •Pregnancy or lactation;
- •Participation in another clinical study with an investigational drug, FSMP or an investigational medical device one month prior to start of study or planned participation in another clinical trial as specified before during the course of the study period;
- •Patient who is unable to understand the spoken and written information or not willing or not able to comply with scheduled visits and the requirements of the study protocol;
- •Considered not suitable for study participation by the investigator
结局指标
主要结局
Change in serum prealbumin
时间窗: from baseline to close out visit (Post-operation Day 5-8)
次要结局
- Change in grip strength(from baseline to Close out Visit(Post-operation Day 5-8))
- Energy intake in kcal / kg BW(from baseline to Close out Visit(Post-operation Day 5-8))
- Change in total number of CD4+and CD8+(from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8))
- Change in serum prealbumin(from baseline to Visit 2（Pre-operation Day 1）, Visit 3（Post-operation Day 1） and Visit 4（Post-operation Day 5 or 6）)
- Change in serum albumin(from baseline to Visit 3（Post-operation Day 1） and close out visit(Post-operation Day 5-8))
- Change in CRP(from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8))
- Change in total lymphocyte count(from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8))
- Change in CD4+ T lymphocytes /CD8+ T lymphocytes(from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8))
- Change in body weight (%)(from baseline to Visit 2（Pre-operation Day 1）, Visit 4（Post-operation Day 5 or 6） and close out visit(Post-operation Day 5-8))
- Change in BMI(from baseline to close out visit(Post-operation Day 5-8))
- Change in PG-SGA(from baseline to Close out Visit(Post-operation Day 5-8))
- Change in blood glucose(from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8))
- Change in lipids(from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8))
- Change in ECOG performance status(from baseline to Close out Visit(Post-operation Day 5-8))
- Change in CD4+ % and CD8+%(from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8))
- Change in neutrophil/lymphocyte ratio(from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8))
- All adverse events (AEs), including serious adverse events (SAEs) for assessment of safety and tolerability(from baseline to Close out Visit(Post-operation Day 5-8))
研究者
研究点 (15)
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