Perioperative Nutritional Optimization in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Rate of post-operative wound complications
研究概览
简要总结
This randomized clinical trial studies how well Nestle Impact Advanced Recovery works in improving surgery recovery in patients with head and neck cancer. Adding a nutritional supplement, such as Nestle Impact Advanced Recovery to a regular diet before and after head and neck cancer surgery may help to decrease the number of wound complications after surgery.
详细描述
PRIMARY OBJECTIVES:
I. Assess the effect of perioperative use of Nestle Impact Advanced Recovery (AR) on the rate of post-operative wound complications within 30 days after major head and neck surgery.
SECONDARY OBJECTIVES:
I. Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications.
II. Assess whether Nestle IMPACT AR decreases the rate of other post-operative complications such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile colitis within 30 days of surgery, as well as length of hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Members of all races and ethnic groups will be included
- •Patients must be diagnosed with cancer of the head and neck and must be surgical candidates
- •Patients must be indicated for major head and neck surgery, defined as surgeries with an anticipated post-surgical hospital stay of 4 or more days; examples of major surgeries include, but are not limited to, total laryngectomy, large oral cavity, oropharyngeal, salivary gland, or soft tissue resections requiring free flap or major regional flap (e.g. pectoralis major flap), and large skull base procedures requiring extensive skull base reconstruction
- •Patients must have cross-sectional body imaging (positron emission tomography [PET]-computed tomography [CT] or equivalent) performed within 4 weeks of study enrollment and available for review
- •Patient must be willing to receive Nestle IMPACT Advance Recovery for five days prior to planned surgery as well as for 5 days after surgery
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients with known distant metastases or other malignancies
- •Patients unable to tolerate oral intake by mouth or per enteral feeding tube
- •Patients with galactosemia
- •Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
- •Patients currently taking IMPACT or other immunonutrition products (arginine-containing supplements) will be excluded; other forms of nutritional supplementation, such as caloric supplementation, tube feeding, or other dietary supplements are allowed on study
- •Patients currently taking anabolic steroids will be excluded; patients taking corticosteroids are allowed on study
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Excluded patients will be allowed to participate in the trial on an observational basis only
结局指标
主要结局
Rate of post-operative wound complications
时间窗: Within 30 days after major head and neck surgery
A patient is found to have a post-operative complication is one of the following is observed: wound infection, seroma, wound dehiscence, fistula formation, free tissue flap loss. A 2-sided 95% confidence interval will also be calculated for each arm, using exact methods, and chi square testing will be performed to compare the incidence of wound complications within 30 days after surgery between control and experimental groups. A multivariate analysis of the primary endpoint will be performed with logistic regression to include study treatment, presence of sarcopenia, prior radiation therapy, a
次要结局
- Sarcopenia(Within 30 days after major head and neck surgery)
- Rate of other post-operative complications(Within 30 days after surgery)
研究者
Daniel Clayburgh
Principal Investigator
OHSU Knight Cancer Institute