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

Primary Purpose

Cancer, Surgery, Fatigue

Status
Withdrawn
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
PG2
Placebo
Sponsored by
PhytoHealth Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring cancer-related fatigue, Palliative Abdominal Surgery, HRQL

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PG2

Placebo

Arm Description

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

Control group: Placebo (500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery

Outcomes

Primary Outcome Measures

change from baseline fatigue status
qustionnaires

Secondary Outcome Measures

Length of hospital stay
Postoperative complications
patients were observed for surgical and nonsurgical complication
Health-related Quality of Life (HRQL)
Inflammatory biomarkers: Serum IFN-r, IL-1b, IL-4, IL-6, IL-10 and TNF-a
The duration of antibiotic therapy
Mortality during the hospital stay
Weight loss
patients will be measured during follow-up period
Body composition
such as protein, mineral, body fat mass

Full Information

First Posted
February 24, 2014
Last Updated
June 13, 2022
Sponsor
PhytoHealth Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02077621
Brief Title
Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer
Official Title
The Phase II Clinical Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study reevaluation
Study Start Date
February 2014 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhytoHealth Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Surgery, Fatigue
Keywords
cancer-related fatigue, Palliative Abdominal Surgery, HRQL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PG2
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control group: Placebo (500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery
Intervention Type
Drug
Intervention Name(s)
PG2
Other Intervention Name(s)
PG2 injection 500mg
Intervention Description
Powder for Injection, 500 mg PG2/500 ml normal saline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
500 mL normal saline
Primary Outcome Measure Information:
Title
change from baseline fatigue status
Description
qustionnaires
Time Frame
a day before surgery and day 1,2,7,28,56,84 after surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
13 weeks
Title
Postoperative complications
Description
patients were observed for surgical and nonsurgical complication
Time Frame
13 weeks
Title
Health-related Quality of Life (HRQL)
Time Frame
a day before surgery and for day 7,28,56,84 after surgery
Title
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
Title
The duration of antibiotic therapy
Time Frame
13 weeks
Title
Mortality during the hospital stay
Time Frame
13 weeks
Title
Weight loss
Description
patients will be measured during follow-up period
Time Frame
13 weeks
Title
Body composition
Description
such as protein, mineral, body fat mass
Time Frame
a day before surgery and for day 28 after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Ming Wu, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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