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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cancer Surgery Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

PG2

Intervention Type DRUG

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

Placebo

Control group:

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

500 mL normal saline

Interventions

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PG2

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

Intervention Type DRUG

Placebo

500 mL normal saline

Intervention Type DRUG

Other Intervention Names

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PG2 injection 500mg

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No