Study of PG2 Injection for Improving Fatigue in Patients... | NCT02077621

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

NCT02077621

Sponsor

PhytoHealth Corporation

Status

Withdrawn

Last Update Posted

Jun 4, 2025Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Cancer
Surgery
Fatigue

Interventions

PG2
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study reevaluation

Expanded Access Info

Start Date

Feb 2014Estimated

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Actual

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Mar 2, 2014

First Posted Date

Mar 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PG2	Experimental	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
Placebo	Placebo Comparator	Control group: Placebo (500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PG2	Drug	Powder for Injection, 500 mg PG2/500 ml normal saline	PG2

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Length of hospital stay		13 weeks
Postoperative complications	patients were observed for surgical and nonsurgical complication	13 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jin-Ming Wu, M.D.	National Taiwan University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009369	Neoplasms
D005221	Fatigue

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms