NL-OMON50399已完成不适用
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 - PROTEOS study
utricia Research0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histologically proven CRC stage IIB, III or IV or histologically or
- •cytologically proven NSCLC stage III or IV
- •2. Eligible and scheduled for first line chemotherapy, concurrent
- •chemoradiotherapy or immunotherapy treatment with a planned duration of at
- •least 12 weeks
- •3. Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- •4. Age >= 18 years
- •5. Written informed consent
排除标准
- •1. Scheduled for first line chemotherapy, concurrent chemoradiotherapy or
- •immunotherapy treatment starting <=4 days after randomization
- •2. Received >10 doses of radiotherapy within 2 months prior to the study
- •3. Weight loss >10% in the last 6 months
- •4. Body Mass Index < 20.0 kg/m2
- •5. Life expectancy < 3 months
- •6. Prescription of oral nutritional supplementation (ONS) before start of first
- •line treatment based on hospital*s standard practice
- •7. Presence of ileostoma or ileal pouch
- •8. Contra-indications to oral feeding, high protein nutrition or to the test
- •product (including galactosaemia) in the opinion of the investigator
- •9. Known pregnancy or lactation
- •10. Current alcohol or drug abuse in the opinion of the investigator
- •11. Investigator's uncertainty about the willingness or ability of the subject
- •to comply with the protocol requirements
- •12. Participation in any other studies involving investigational or marketed
- •products concomitantly or within two weeks prior to entry into the study
研究者
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