NCT05495360已完成不适用
Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients
Nutricia Research6 个研究点 分布在 3 个国家目标入组 48 人开始时间: 2023年1月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids]
研究概览
简要总结
A single arm intervention study examining the effect of an omega 3 enriched oral nutritional supplement on nutritional status of CRC and NSCLC patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically proven CRC or histologically or cytologically proven NSCLC
- •Eligible and scheduled for at least 2 cycles of 4-week cycles of systemic treatment, 3 cycles of 3-week cycles of systemic treatment or 4 cycles of 2-week cycles of systemic treatment
- •At risk of malnutrition or malnourished [PG-SGA-SF > 4]
- •Performance status ECOG 0 or 1
- •Weight loss grade 0-3 according to Martin et al1
- •<11% weight loss in the past 6 months
- •Age ≥ 18 years
- •Written informed consent
排除标准
- •Presence of ileostoma or ileal pouch
- •GI-related or major surgery in 30 days prior to baseline
- •Severe hypercalcemia, i.e. total calcium level, corrected for albumin ≥ 14.0 mg/dL (3.5 mmol/L)
- •Use of ONS, enteral nutrition or parenteral nutrition within 14 days prior to entry into the study
- •Use of fish oil containing supplements, within 30 days prior to entry into the study or expected to use this during the study
- •Use of more than 200 iU/day of vitamin D containing supplements within 30 days prior to entry into the study or expected to use this during the study
- •Life expectancy of < 3 months
- •Severe renal dysfunction (<29 ml/min/1.73m2 eGRF or albumin:creatinine (ACR) > 30) or hepatic encephalopathy
- •Allergy to cow's milk protein or fish, known protein sensitivity or suffering galactosemia
- •Known pregnancy or lactation
- •Current alcohol or drug abuse in opinion of the investigator
- •Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
结局指标
主要结局
Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids]
时间窗: at end of first in-study treatment cycle compared to baseline
次要结局
- Change in protein intake [g/day] [key secondary outcome)(at end of first in-study treatment cycle compared to baseline)
- Change in energy intake [kcal/day](at end of first in-study treatment cycle compared to baseline)
- Change in protein intake [g/kg bw/day] [key secondary outcome)(at end of first in-study treatment cycle compared to baseline)
- Change in fatty acid profile in the phospholipid fraction of the cell membrane of erythrocytes [% of total fatty acids](at end of first in-study treatment cycle compared to baseline)
- Change in energy intake [kcal/kg bw/day](at end of first in-study treatment cycle compared to baseline)
- Provided vitamin D supplementation [µg/day] by the test product(Throughout total intervention period - about 2 months)
研究者
研究点 (6)
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