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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer; Fatigue; Surgery
• Intervention / Treatment: Drug: PG2; Drug: Placebo

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).

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PhytoHealth Corporation
• Investigators: Principal Investigator: Jin-Ming Wu, M.D., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2014
• Primary Completion (Estimated): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: March 2, 2014
• First Posted (Estimated): March 4, 2014

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: HRQL; cancer-related fatigue; Palliative Abdominal Surgery
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: PH-CP020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No