NCT02515032已完成不适用
A 12-week Double Blind, Placebo Controlled, Randomised Pilot Study Assessing Safety and Tolerability of Nutrifriend Cachexia in Patients Diagnosed With Non Small Cell Lung Cancer (NSCLC) With Involuntary Weight Loss
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Smartfish AS
- 入组人数
- 56
- 试验地点
- 28
- 主要终点
- Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC
研究概览
简要总结
SF-C002 is a pilot study in patients with newly diagnosed NSCLC suffering from involuntary weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective is to study the safety and tolerability of Nutrifriend Cachexia.
详细描述
This study is a 12-week, randomised, parallel group, placebo controlled, multi-centre study. The primary objective is to evaluate the safety and tolerability of Nutrifriend Cachexia in patients with NSCLC. The secondary objectives of the study are to evaluate effects on body composition, muscle function, daily activity, inflammation, tumor growth, compliance, appetite and Quality of Life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-line standard chemotherapy as curative or palliative treatment for NSCLC
- •Will start the first cycle of standard chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- •Involuntary weight loss
排除标准
- •Another invasive malignancy in the last 2 years.
- •Previous relapse of NSCLC within 2 years of randomisation
- •Other cachectic disorders such as renal or hepatic disorders
结局指标
主要结局
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC
时间窗: 12 weeks
次要结局
- Compliance assessed by vitamin D levels(12 weeks)
- Body composition assessed by weight(12 weeks)
- Body composition assessed by waist circumference(12 weeks)
- QoL assessed by EORTC QLQ-C3(12 weeks)
- QoL assessed by Nutrition Appetite Questionnaire (CNAQ)(12 weeks)
- Body composition assessed by fat mass and lean body mass (LBM)(12 weeks)
- Function assessed by grip strength(12 weeks)
- Function assessed by walking distance(12 weeks)
- Metabolic markers(12 weeks)
- QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire(12 weeks)
- Compliance assessed by Drinks consumed(12 weeks)
- Body composition assessed by BMI(12 weeks)
- Function assessed by 6 minute walking test(12 weeks)
- Compliance assessed by Omega-3 incorporation(12 weeks)
- Inflammation(12 weeks)
- Body composition assessed by calf circumference(12 weeks)
研究者
研究点 (28)
Loading locations...
相似试验
进行中（未招募）
不适用
A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary Efficacy Study of K201 Oral for the Prevention of Atrial Fibrillation (AF) Recurrence in Subjects Post-Conversion from AF - ARCTIC-AFMedDRA version: 12.1Level: LLTClassification code 10003658Term: Atrial fibrillationAtrial FibrillationEUCTR2009-017838-44-DKSequel Pharmaceuticals, Inc.300
进行中（未招募）
不适用
A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary Efficacy Study of K201 Oral for the Prevention of Atrial Fibrillation (AF) Recurrence in Subjects Post-Conversion from AF - ARCTIC-AFAtrial FibrillationEUCTR2009-017838-44-SESequel Pharmaceuticals, Inc.300
进行中（未招募）
不适用
A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary Efficacy Study of K201 Oral for the Prevention of Atrial Fibrillation (AF) Recurrence in Subjects Post-Conversion from AF - ARCTIC-AFAtrial FibrillationEUCTR2009-017838-44-FISequel Pharmaceuticals, Inc.300
进行中（未招募）
1 期
A Pilot Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centred Safety, Tolerability and Preliminary EfficacyStudy of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion from AFAtrial fibrillation is the most common arrhythmia encountered in clinical practice. Atrial fibrillation is usually associated with age and general physical condition, rather than with a specific cardiac event. While not directly life-threatening, atrial arrhythmias can cause discomfort and can lead to stroke or congestive heart failure, and overall, increase morbidity.EUCTR2005-004713-15-DKCardiome Pharma Corp.
进行中（未招募）
不适用
A Pilot Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centred Safety, Tolerability and Preliminary EfficacyStudy of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion from AFAtrial fibrillation is the most common arrhythmia encountered in clinical practice. Atrial fibrillation is usually associated with age and general physical condition, rather than with a specific cardiac event. While not directly life-threatening, atrial arrhythmias can cause discomfort and can lead to stroke or congestive heart failure, and overall, increase morbidity.EUCTR2005-004713-15-CZCardiome Pharma Corp.180