NCT02077621

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: PhytoHealth Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cancer
• Surgery
• Fatigue

Interventions

Type	Name	Description
DRUG	PG2	Powder for Injection, 500 mg PG2/500 ml normal saline
DRUG	Placebo	500 mL normal saline

Timeline

• Start date: 2014-02-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2014-03-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: Taiwan