NCT02848807Unknown不适用
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study
University Clinical Centre, Gdansk1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Chemotherapy-related toxicity during 12th week of observation
研究概览
简要总结
Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.
详细描述
Other endpoints:
- to determine whether high protein ONS influence on the nutritional status
- to determine whether high protein ONS influence on the quality of life
- to determine whether high protein ONS influence on the performance status
- to determine high protein ONS tolerability / ONS intake compliance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •histological confirmed diagnosis of CRC in clinical stage IV
- •successful qualification to chemotherapy
- •performance status at least 80% according to Karnofsky scale and <2 according to WHO/ECOG scale
- •cancer-related asymptomatic precachexia diagnosed
- •absence of contraindications to oral nutrition and practicable realization of oral nutrition
- •absence of severe, decompensated concomitant diseases
- •signed informed consent for the participation in the study
排除标准
- •diagnosis of a malignant neoplasm in clinical stage I-III
- •disqualification from oncologic treatment
- •cancer cachexia or cancer anorexia-cachexia syndrome
- •poor performance status
- •contraindications to oral nutrition or to high protein nutrition
- •regular nutritional support at the moment of qualification to the study
- •patient incompliance at the moment of qualification to the study
结局指标
主要结局
Chemotherapy-related toxicity during 12th week of observation
时间窗: at baseline and after 12th week
graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4.0); to determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy during 3 months observation period (comparison of the results at the baseline and after 12 weeks)
次要结局
- Changes in the Nutritional status / metabolic status(at baseline and after 12th week)
- Changes in the Performance status(at baseline and after 12th week)
- Changes in the Quality of life and patients well-being(at baseline and after 12th week)
研究者
研究点 (1)
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