The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Time to Return of Upper and Lower GI Function
研究概览
简要总结
The purpose of this study is to investigate the ability of alvimopan to reduce the time to return of bowel function in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half will receive placebo immediately before and for up to seven days after surgery.
详细描述
Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a surgical procedure to treat cancer that has spread to the lining of the abdominal cavity (peritoneal metastases). It is associated with a prolonged time for return of bowel function after surgery.
Alvimopan is a drug used to speed up the time for return of bowel function after surgery. It works by blocking the opioid receptors in the gastrointestinal tract, which normally slow down bowel function in patients receiving postoperative opioid pain medication. It has not previously been tested in patients undergoing CRS/HIPEC.
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
- Triple (Participant, Care Provider, 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
- •Ability to understand and the willingness to sign a written informed consent.
- •Scheduled to undergo open (non-minimally invasive) CRS/HIPEC.
- •Scheduled to receive postoperative pain management with intravenous opioids.
- •Age > 18 years.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤
- •Women of child-bearing potential with negative pregnancy test prior to initiating study drug dosing.
排除标准
- •Greater than 7 days of consecutive opioid use immediately prior to scheduled surgery.
- •Child-Pugh Class C hepatic impairment.
- •End-stage renal disease (GFR < 15 mL/min/1.73 m2 and/or on peritoneal dialysis or hemodialysis).
- •Complete mechanical bowel obstruction.
- •Contraindication or inability to tolerate oral medication postoperatively.
- •Presence of gastrointestinal ostomy after CRS/HIPEC.
- •Pancreatic or gastric anastomosis performed during CRS/HIPEC.
- •History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition as alvimopan at the treating investigators discretion.
- •Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e. uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
- •History of myocardial infarction in the 12 months prior to scheduled surgery.
- •Pregnant or nursing.
研究组 & 干预措施
Alvimopan
alvimopan 12 mg PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
干预措施: Alvimopan (Drug)
Placebo
Placebo pill PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Return of Upper and Lower GI Function
时间窗: from surgery to discharge (generally no longer than two weeks)
The later of the time from surgery that the participant first tolerates solid food and the time that the participant first passes a bowel movement.
次要结局
- Prolonged Ileus(from surgery to discharge (generally no longer than two weeks))
- Time to Return of Bowel Function Components(from surgery to discharge (generally no longer than two weeks))
- Subgroup Analyses(up to 30 days from surgery)
- Time to Discharge(from surgery to discharge (generally no longer than two weeks))
- Serious Adverse Events(up to 30 days from surgery)
研究者
Joel Baumgartner
Assistant Professor of Surgery
University of California, San Diego