Nutritional Supplementation for Esophageal Cancer Patients Undergoing Trimodality Therapy
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Patient well-being improvement
研究概览
简要总结
This phase III trial studies nutritional supplementation with Impact Advanced Recovery to see how well it works compared with standard nutritional supplementation in reducing complications in patients with esophageal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy, radiation therapy, and/or surgery. Impact Advanced Recovery may help to reduce the number of surgical complications, reduce toxicity, improve nutritional status before surgery, and reduce morbidity after surgery in patients with esophageal cancer.
详细描述
PRIMARY OBJECTIVES:
I. When compared to the current standard of ad hoc nutritional supplementation on an as-needed basis, scheduled enteral supplementation with Impact Advanced Recovery during the course of neoadjuvant therapy (for those in the planned trimodality group), preoperatively, and postoperatively will improve patient wellbeing by reducing weight loss (measured at baseline, preoperatively, and at postoperative follow-up) incurred during the course of therapy and will permit maintenance of patient performance status.
SECONDARY OBJECTIVES:
I. Decrease rates of a composite outcome that includes anastomotic leaks, ileus, major pulmonary events (pneumonia, reintubation, tracheostomy), wound infection, postoperative mortality, chyle leaks, and other postoperative complications.
II. Improve overall survival. III. Return to pre-surgical activity level (measured by Eastern Cooperative Oncology Group [ECOG] at baseline, preoperatively, and at postoperative follow-up).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resectable, locally advanced esophageal cancer (adenocarcinoma, squamous cell, other histology).
- •Medically operable.
- •Treatment plan for (i) chemoradiation then surgery or chemotherapy followed by chemoradiation then surgery, or (ii) salvage esophagectomy.
- •Able to tolerate feeds either orally or via tube gastrostomy or enterostomy.
排除标准
- •Allergy to supplement.
- •Pregnant.
- •Hepatic insufficiency.
- •Serum creatinine > 2.
- •Metastatic disease.
- •Performance status of > or equal to
- •Inability to take either oral intake or enteral feeds or both.
- •Given increased rates of perioperative morbidity and mortality historically observed at our institution, patients undergoing salvage resection for squamous cell carcinoma will not be eligible for enrollment.
结局指标
主要结局
Patient well-being improvement
时间窗: Up to 30 days post-surgery
Will be measured by weight loss change incurred during the course of therapy and maintenance of patient performance status. The composite outcome will be Clavien-Dindo postoperative morbidity (POM) score, which is an ordinal health quality outcome variable with six levels: 0=normal recovery, 1=minor complication, 2=complication requiring pharmaceutical intervention, 3=complication requiring surgical, endoscopic or radiological intervention, 4=life-threatening complication requiring intensive care and 5=complication leading to the patient's death. Each patient will be monitored for up to 30 days after their operation, and their POM score based on this postoperative period will be recorded.
次要结局
未报告次要终点