A Double Blind, Randomised, Placebo Controlled, Feasibility Phase III Clinical Trial of Peri-operative Immune-enhancing Feed in Patients Undergoing Surgery for Advanced Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Systemic infection
研究概览
简要总结
Study Hypothesis: The peri-operative enteral administration of a proprietary immune-enhancing feed (IMPACT) will not reduce post-operative infective complications in patients undergoing major surgery for squamous cell carcinoma of the Head and neck (SCCHN).
Patients who present with SCCHN for whom surgery is the recommended treatment will, assuming they fulfill the eligibility criteria, be block randomised into a two-group, double-blind randomised controlled trial. One group will receive IMPACT, the other an iso-caloric, iso-nitrogenous control feed for 5 days pre and 7 days post-operatively. In both groups patients will be fed enterally. The feeds will be prepared in identical bottles to facilitate blinding. Primary outcome measures include major systemic infection, whilst secondary outcome measures include local infection and length of hospital stay. Follow-up will be for 30 days postsurgery.
详细描述
As above
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
- Double (Participant, Investigator)
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
- •Patients who were to undergo either of the following procedures
- •partial (external approach) or total laryngectomy
- •partial pharyngectomy with primary closure or free-flap reconstruction
- •total pharyngectomy (gastric (or colonic) transposition, other free flap reconstruction, or other pedicled flap reconstruction)
- •oral cavity or oropharyngeal resection requiring reconstruction with a free flap or pedicled flap
排除标准
- •Patients with
- •malabsorption syndromes
- •primary immune disorders
- •active infection on presentation
- •patients undergoing secondary surgical reconstruction
- •patients undergoing palliative surgery
- •patients aged under 18 years old
- •patients who were pregnant or breast feeding
结局指标
主要结局
Systemic infection
时间窗: 30 days post surgery
Lower respiratory tract; Gastro-intestinal tract; Urinary tract; Haematological.
次要结局
- Local/wound site infection(Within 30 days post-surgery)
- Length of post-operative hospital stay(Up to 30 days post surgery)
研究者
Terrence Jones
Professor
Liverpool University Hospitals NHS Foundation Trust