The Phase II Clinical Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- change from baseline fatigue status
研究概览
简要总结
PG2 has been approved in Taiwan to treat cancer-related fatigue for advanced cancer patients. The primary objective of this study is to evaluate the efficacy of PG2 on fatigue relief in patients undergoing palliative abdominal surgery for cancer. The secondary endpoints, including the length of hospital stay, postoperative complications, HRQL, inflammatory biomarkers, the duration of antibiotic therapy, mortality during the hospital stay, weight loss and body composition, will be evaluated among these patients.
详细描述
This will be a double-blind, randomized, and placebo-controlled study. At least 40 evaluable patients who are scheduled for palliative abdominal surgery for cancer will be randomly assigned to the control or treatment group. Each group will have at least 20 patients and be treated as follows: 1) control group: patients will accept placebo 1 dose a day (POD-1) before surgery and 1 dose a day for 3 days after surgery (POD+0 to POD+2); 2) treatment group: patients will accept PG2 1 dose a day (POD-1) before surgery and 1 dose a day for 3 days after surgery (POD+0 to POD+2).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have cancer and are scheduled for palliative abdominal surgery for cancer
- •Age > 20 years older
- •Patients who signed the informed consent form
排除标准
- •Patients, at screening, has levels greater than 2.5 times the upper limit of normal liver function of alanine aminotransferase or aspartate aminotransferase.
- •Patients has a severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2.5 times the upper limit of normal for range); or the subject is on dialysis.
- •Patients have ongoing infection, respiratory tract dysfunction, cardiac dysfunction or immune disorder that, in the opinion of the investigator, may interfere with conduct of the study.
- •Patients who are not suitable for undergoing surgery (e.g. congenital hemostatic disorders) by the investigator's judgment.
- •Patients have enrolled or have not yet completed other investigational drug trials within 1 month before screening.
- •Female patients are pregnant or breast-feeding.
- •Patients who require preoperative nutritional support
- •Patients with serious comorbidities (American Society of Anesthesiologists Risk Class of 4 or 5).
- •Patients who is unwilling or unable to answer the quality of life questionnaires i.e. the BFI-T and EORTC QLQ-C30.
研究组 & 干预措施
PG2
Treatment Group:
PG2 (500 mg in 500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery
干预措施: PG2 (Drug)
Placebo
Control group:
Placebo (500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery
干预措施: Placebo (Drug)
结局指标
主要结局
change from baseline fatigue status
时间窗: a day before surgery and day 1,2,7,28,56,84 after surgery
qustionnaires
次要结局
- Mortality during the hospital stay(13 weeks)
- Body composition(a day before surgery and for day 28 after surgery)
- Health-related Quality of Life (HRQL)(a day before surgery and for day 7,28,56,84 after surgery)
- The duration of antibiotic therapy(13 weeks)
- Length of hospital stay(13 weeks)
- Postoperative complications(13 weeks)
- Inflammatory biomarkers: Serum IFN-r, IL-1b, IL-4, IL-6, IL-10 and TNF-a(Before operation and on day 1, and day 7 after operation)
- Weight loss(13 weeks)