Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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The Phase II Clinical Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer

Conditions
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Cancer, Surgery, Fatigue

Intervention / Treatment
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* Drug: PG2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have cancer and are scheduled for palliative abdominal surgery for cancer Age > 20 years older Patients who signed the informed consent form Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PG2<br>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 | Drug: PG2<br>* Powder for Injection, 500 mg PG2/500 ml normal saline<br>* Other names: PG2 injection 500mg;|
| Placebo Comparator: Placebo<br>Control group: Placebo (500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery | Drug: Placebo<br>* 500 mL normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline fatigue status | qustionnaires | a day before surgery and day 1,2,7,28,56,84 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 13 weeks | 
| Postoperative complications | patients were observed for surgical and nonsurgical complication | 13 weeks | 
| Health-related Quality of Life (HRQL) |  | a day before surgery and for day 7,28,56,84 after surgery | 
| 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 | 
| The duration of antibiotic therapy |  | 13 weeks | 
| Mortality during the hospital stay |  | 13 weeks | 
| Weight loss | patients will be measured during follow-up period | 13 weeks | 
| Body composition | such as protein, mineral, body fat mass | a day before surgery and for day 28 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer-related fatigue, Palliative Abdominal Surgery, HRQL