Whey Protein Supplementation in Malnourished Cancer Patients: a Randomized, Controlled Trial
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
- 否
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
Nutritional counseling
干预措施: Nutritional counseling (Other)
Whey protein
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
Emanuele Cereda
Physician
Fondazione IRCCS Policlinico San Matteo di Pavia
