Cancer, Fatigue, Surgery
Conditions
Keywords
cancer-related fatigue, Palliative Abdominal Surgery, HRQL
Brief summary
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
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).
Interventions
DRUGPG2
Powder for Injection, 500 mg PG2/500 ml normal saline
DRUGPlacebo
500 mL normal saline
Sponsors
PhytoHealth Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline fatigue status | a day before surgery and day 1,2,7,28,56,84 after surgery | qustionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 13 weeks | patients were observed for surgical and nonsurgical complication |
| 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 | — |
| Length of hospital stay | 13 weeks | — |
| Mortality during the hospital stay | 13 weeks | — |
| Weight loss | 13 weeks | patients will be measured during follow-up period |
| Body composition | a day before surgery and for day 28 after surgery | such as protein, mineral, body fat mass |
| The duration of antibiotic therapy | 13 weeks | — |
Countries
Taiwan
Outcome results
None listed