Efficacy of Immunonutrition in Improving Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
研究概览
简要总结
The aim of the present project is to evaluate in a randomised, controlled, open-label, two parallel treatment groups pilot study, the efficacy of oral nutritional supplementation with a high-protein-high calorie mixture containing immunonutrients compared to a standard high-calorie-high-protein nutritional blend, in addition to nutritional counseling, in improving tolerance to chemoradiotherapy (CT-RT) in patients with tumours of the head and neck
详细描述
In a recent study, we have shown that the systematic use of oral nutritional supplements (ONS) in combination with counseling further favours the maintenance of nutrition status, the recovery of quality of life and, more importantly, improves the practicability of CT-RT. This effect would be substantially attributable to the increase in protein-energy intake associated with ONS use, but also to the possible "nutraceutical" action of omega-3 fatty acids. Therefore, modulation of the inflammatory response could play a role during cancer treatments. In this context, there is an already-known high-calorie-high-protein nutritional blend, enriched in immunonutrients (arginine, nucleotides and omega-3 fatty acids), which could also have an application in this type of patients. This mixture has proven effective in reducing the risk of post-operative complications (e.g. infections, fistulas, etc.) and the length of stay of patients undergoing major cancer surgery (abdominal and head and neck regions). Nevertheless, in oncology, there is a growing therapeutic interest in the modulation of inflammation and immunosuppression at the tumour microenvironment level.
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
- Single (Outcomes Assessor)
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
- •diagnosis of head-neck cancer
- •indication to curative or adjuvant chemoradiotherapy
- •availability to planned measurements and to written informed consent.
排除标准
- •age <18 years
- •indication to or ongoing artificial nutrition
结局指标
主要结局
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
时间窗: 9 weeks
Difference in the incidence of grade \>=3 toxicity, according to CTCAE v5.0
次要结局
- Total radiotherapy dose(9 weeks)
- Energy intake(9 weeks)
- Duration of treatment(9 weeks)
- Treatment-related adverse events as assessed by CTCAE v5.0(9 weeks)
- Skeletal muscle mass(9 weeks)
- Objective response rate(9 weeks)
- Body weight(9 weeks)
- Handgrip strength(9 weeks)
- Self-perceived quality of life(9 weeks)
- Patients requiring unplanned hospitalization(9 weeks)
- Adherence to treatment schedule(9 weeks)
- Total chemotherapy dose(9 weeks)
- Toxicity-free survival(9 weeks)
- Fatigue(9 weeks)
研究者
Riccardo Caccialanza
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia