Perioperative Nutritional Optimization in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Assess the effect of perioperative use of Nestle Impact AR
研究概览
简要总结
To determine whether nutritional optimization in head and neck cancer patients undergoing major surgery will decrease post-operative wound complications. The Investigators hypothesize that nutritional supplementation with Nestle Impact Advanced Recovery (AR) will decrease the rate of wound complications after surgery
详细描述
The purpose of this study is to determine whether nutritional optimization in head and neck cancer patients undergoing major surgery will decrease post-operative wound complications. It is likely that many head and neck cancer patients suffer from sarcopenia, and this contributes to many wound complications, including wound infection, dehiscence, fistula formation, and free flap tissue loss. The Investigators hypothesize that nutritional supplementation with Nestle Impact Advanced Recovery (AR) will decrease the rate of wound complications after surgery
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
- •Age >18 years. Both men and women and 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 (PET-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.
- •All adult men and women with cancer of the head and neck undergoing surgery by the study PI's at UI Health will be considered for participation in this study without regard to race, gender or socioeconomic status.
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 immuno-nutrition 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.
研究组 & 干预措施
Standard enteral tube feeds
Patients will be instructed to continue a normal diet before surgery. Post-operatively, patients will receive standard of care isocaloric and iso-nitrogenous standard enteral tube feeds
干预措施: Isocaloric and iso-nitrogenous standard enteral tube feeds (Dietary Supplement)
Nestle IMPACT AR
Patients will be encouraged to continue their regular diet until their surgery day. In addition, beginning 5 days before surgery, subjects will be instructed to drink three, 6 ounce cartons of Nestle IMPACT AR each day until their surgery. Post operatively patients who are able to eat orally, will be given three, 6 ounce cartons of Nestle IMPACT AR to drink each day for 5 days. Patients who are not able to tolerate an oral diet will be given Nestle IMPACT via a continuous tube feeding for 5 days through a temporary nasogastric feeding tube placed per standard post-operative care. Dosing of the tube feeding will be based on weight at a rate of approximately 70-75 cc/hour.
干预措施: Nestle IMPACT AR (Dietary Supplement)
结局指标
主要结局
Assess the effect of perioperative use of Nestle Impact AR
时间窗: 30 days post-op
Assess the rate of post-operative wound infection
Assess the effect of perioperative use of Nestle Impact AR
时间窗: 30 days
Assess the rate of post-operative seroma
次要结局
- Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications(30 days post-op)
研究者
Barry Lloyd Wenig
Principal Investigator
University of Illinois at Chicago