NCT02077621

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2014

Longer than P75 for phase_2 cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

6.8 years

First QC Date

February 24, 2014

Last Update Submit

June 2, 2025

Conditions

CancerSurgeryFatigue

Keywords

cancer-related fatiguePalliative Abdominal SurgeryHRQL

Outcome Measures

Primary Outcomes (1)

  • change from baseline fatigue status

    qustionnaires

    a day before surgery and day 1,2,7,28,56,84 after surgery

Secondary Outcomes (8)

  • Length of hospital stay

    13 weeks

  • Postoperative complications

    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

  • +3 more secondary outcomes

Study Arms (2)

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

PG2DRUG

Powder for Injection, 500 mg PG2/500 ml normal saline

Also known as: PG2 injection 500mg
PG2
PlaceboDRUG

500 mL normal saline

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have cancer and are scheduled for palliative abdominal surgery for cancer
  • Age \> 20 years older
  • Patients who signed the informed consent form

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jin-Ming Wu, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 4, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 4, 2025

Record last verified: 2025-06

Locations

TW(1)