Protein Intake in Patients With Colorectal or Lung Cancer During First Line Treatment With Chemo (Radio) - or Immunotherapy When Receiving a Low Volume, Energy Dense and High Protein Oral Nutritional Supplement: a Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 14
- 主要终点
- The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.
研究概览
简要总结
The PROTEOS study is an randomized controlled, open label, parallel-group, multi-centre and multicounty interventional study to assess the acceptance and implementation of Compact Protein, a low volume, energy dense and high protein oral nutritional support in clinical practice according to the ESPEN guidelines in colorectal and lung cancer patients undergoing chemo(radio)- or immunotherapy treatment.
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
盲法说明
randomised controlled, open label, parallel-group, multi-centre and multicountry study
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 stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV
- •Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks
- •Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- •Age ≥ 18 years
- •Written informed consent
排除标准
- •Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ≤4 days after randomization
- •Received radiotherapy within 2 months prior to the study
- •Weight loss >10% in the last 6 months
- •Body Mass Index < 20.0 kg/m2
- •Life expectancy < 3 months
- •Prescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital's standard practice
- •Presence of ileostoma or ileal pouch
- •Contra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigator
- •Known pregnancy or lactation
- •Current alcohol or drug abuse in the opinion of the investigator
- •Investigator's uncertainty about the willingness or ability of the subject 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
研究组 & 干预措施
Control group
Test group
125 mL Fortimel/Nutridrink Compact Protein
干预措施: 125 mL Fortimel/Nutridrink Compact Protein (Dietary Supplement)
结局指标
主要结局
The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.
时间窗: end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.
次要结局
- Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake(end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks))
- Change of body weight.(during 12 weeks (baseline till end of intervention at week 12])