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临床试验/NCT02065726
NCT02065726已完成不适用

Whey Protein Supplementation in Malnourished Cancer Patients: a Randomized, Controlled Trial

Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2014年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
166
试验地点
2
主要终点
Body composition

研究概览

简要总结

Nutritional derangements are very common in cancer patients and negatively affect survival, morbidity and quality of life. Intervention trials have demonstrated that nutritional counseling can improve energy balance, nutritional status and quality of life in patients undergoing chemo-radiotherapy. Oxidative stress plays a role in the tumor-cytotoxic effect of cancer chemotherapy and radiotherapy but may also play a role therapy-related adverse events such as an impairment of nutritional status and quality of life. The nutritional properties of whey protein have recently raised attention. In view of the high content in cysteine these proteins can positively stimulate the synthesis of glutathione which, in turn, could contribute to the modulation of whole-body and cellular redox state. However, evidence on the role of this dietary intervention in cancer patients is limited.

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
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

入选标准

  • Cancer patients (lung, gastric, pancreatic, breast, colon, esophageal)
  • Eastern Cooperative Oncology Group performance status ≤ 2
  • Weight loss >= 10% in the last 6 months
  • Chemotherapy
  • Written informed consent

排除标准

  • Age < 18 years
  • Ongoing artificial nutrition (enteral or parenteral)
  • Unavailability to planned measurements

研究组 & 干预措施

Nutritional counseling

Active Comparator

Nutritional counseling

干预措施: Nutritional counseling (Other)

Whey protein

Experimental

Nutritional counseling + 20 g (2 x 10 g) of whey proteins (Prother® - Spepharm Italy)

干预措施: Whey protein (Dietary Supplement)

结局指标

主要结局

Body composition

时间窗: 3 months

Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)

次要结局

  • Body composition(1 month)
  • Body weight(3 months)
  • Quality of life(3 months)
  • Handgrip strength(3 months)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emanuele Cereda

Physician

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (2)

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