Open-label, Randomized, Multicenter, Phase IV Trial Comparing Parenteral Nutrition Using Eurotubes® vs. Traditional 2/3-chamber Bags in Subjects With Metastatic or Localized Solid Tumors Requiring Parenteral Nutrition - The PEKANNUSS Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 142
- 试验地点
- 15
- 主要终点
- patients' autonomy
研究概览
简要总结
Patients with inoperable metastatic or localized solid tumors who have an indication for parenteral nutrition will be enrolled and receive standard parenteral nutrition according to randomization using either 2/3-chamber bags or Eurotubes®, the latter either with or without reduced glucose. The main goal of the trial is to compare the frequency of self-administered parenteral nutrition at home (autonomy rate).
详细描述
This is an open-label, randomized, multicenter, investigator-initiated, phase IV trial. A total number of 216 patients will be enrolled.
Patients will be stratified according to ECOG (0-1 vs. 2 vs. 3), the modified Glasgow Prognostic Score (mGPS) (0-1 vs. 2) and whether the patient receives concurrent systemic anti-tumor treatment or not.
In a first step, patients will be randomized in a 2:1 ratio to Arm A (Standard Parenteral Nutrition using Eurotubes®) or Arm B (Standard Parenteral Nutrition using 2/3-chamber bags). Patients in Arm A will be stratified again by the same criteria as listed above and randomized in a 1:1 ratio to Arm A-1 (Standard Low Glucose Parenteral Nutrition using Eurotubes®) or Arm A-2 (Standard Parenteral Nutrition using Eurotubes®). Within the study, the patient can receive PN for a maximum of 12 months after randomization as long as the PN is still indicated and deemed necessary by the investigator.
Primary objective is to compare the frequency of self-administered parenteral nutrition at home (HPN). Main secondary objectives are to compare the incidence of catheter related infections (CRI), to compare the efficacy of parenteral nutrition (PN) in terms of body weight, C-reactive protein (CRP) and albumin levels, and overall survival (OS), to compare the Quality of life (QoL) by use of a modified HPN-PROQ questionnaire, to determine the frequency and duration of visits by the nursing service and to compare specified safety parameters.
The HPN therapy plan determined at screening and any modifications and adjustments to this plan during the course of HPN treatment will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Histologically confirmed metastatic or localized solid tumor. Perioperative setting of HPN is allowed if HPN is planned for a duration of ≥ 2 months
- •ECOG performance status of 0, 1, 2 or 3
- •Indication for PN (the subject needs a PN independent of the trial)
- •PN planned for 3 or more days per week
- •Negative pregnancy test in women of childbearing potential
- •Willingness to perform double-barrier contraception during study for women of childbearing potential
- •Willingness to maintain a study diary
- •Life expectancy > 3 months
- •Written informed consent
排除标准
- •> 4 weeks of consecutive (3 ≥ days per week) parenteral nutrition in the last 3 months prior to study enrolment
- •Participation in another interventional clinical trial that could influence the endpoints of this trial or planned participation in such a study at the same time as this study is active (participation in other trials is possible in the follow up time for OS). The study is active, if the patients receive study treatment (PN), did not discontinue the trial for other reasons, and is still within the 12 months active study period
- •Current catheter related infection at baseline
- •Pregnancy or breastfeeding
- •Known hypertriglyceridemia ≥ CTCAE grade 3
- •Unable or unwilling to provide written informed consent and to comply with the study protocol
- •Uncontrolled diabetes mellitus
- •Congestive heart failure NYHA ≥ 3
- •Renal insufficiency GFR < 30 ml/min
- •Uncontrolled infection
- •Liver insufficiency
结局指标
主要结局
patients' autonomy
时间窗: up to 1 year
Rate of self-administered parenteral nutrition at home (autonomy rate), defined as administration without nursing service assistance, as documented within the patient's study diary and calculated as the number of patients with autonomy divided by the total number of patients in the respective arm. Autonomy - as relevant for the primary endpoint - is achieved if the patient self-administers 70% or more of her/his total administrations (Note: Help of family members or other personal caregivers accounts for self-administration).
次要结局
- Relative weight change(up to 1 year)
- Relative change of albumin and CRP(up to 1 year)
- Overall survival(up to 4 years)
- Incidence and severity of adverse events(up to 12 months)
- Patient reported outcomes - Quality of life(up to 12 months)