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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
National Taiwan University Hospital
Taipei, Taiwan
change from baseline fatigue status
qustionnaires
Time frame: a day before surgery and day 1,2,7,28,56,84 after surgery
Length of hospital stay
Time frame: 13 weeks
Postoperative complications
patients were observed for surgical and nonsurgical complication
Time frame: 13 weeks
Health-related Quality of Life (HRQL)
Time frame: 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
Time frame: Before operation and on day 1, and day 7 after operation
The duration of antibiotic therapy
Time frame: 13 weeks
Mortality during the hospital stay
Time frame: 13 weeks
Weight loss
patients will be measured during follow-up period
Time frame: 13 weeks
Body composition
such as protein, mineral, body fat mass
Time frame: a day before surgery and for day 28 after surgery
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