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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02077621
• Other study ID #: PH-CP020
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2014
• Est. completion date: December 2020

Study information

• Verified date: November 2023
• Source: PhytoHealth Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Fatigue
• Surgery

Intervention

Drug:
• PG2
Powder for Injection, 500 mg PG2/500 ml normal saline
• Placebo
500 mL normal saline

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
PhytoHealth Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline fatigue status	qustionnaires	a day before surgery and day 1,2,7,28,56,84 after surgery
Secondary	Length of hospital stay		13 weeks
Secondary	Postoperative complications	patients were observed for surgical and nonsurgical complication	13 weeks
Secondary	Health-related Quality of Life (HRQL)		a day before surgery and for day 7,28,56,84 after surgery
Secondary	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
Secondary	The duration of antibiotic therapy		13 weeks
Secondary	Mortality during the hospital stay		13 weeks
Secondary	Weight loss	patients will be measured during follow-up period	13 weeks
Secondary	Body composition	such as protein, mineral, body fat mass	a day before surgery and for day 28 after surgery