PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care

June 2, 2025 updated by: PhytoHealth Corporation

The objective of this study is to conduct a trial in the spirit of providing as much as possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and safety of PG2 for relieving fatigue among advanced cancer patients who are under standard palliative care (SPC) at hospice setting and have no further curative options available. Patient's fatigue status, to be measured by the Brief Fatigue Inventory-Taiwanese Form (BFI-T), will be the primary endpoint. The fatigue improvement response rate among patients between two study arms will then be compared as the basis for efficacy evaluation at the end of the first treatment cycle, and will be the primary endpoint. Other endpoints, the fatigue improvement response rate and the mean fatigue scores change from baseline among patients within and between cycles will be included in the secondary efficacy endpoints, and will be compared between two study arms. Patients' quality of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life (QoL) will be also measured by 11 questions (SS11) from EORTC QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints include Karnofsky performance scores, and weight change and its related c-reactive protein level of the patients.

* BFI-T (Brief Fatigue Inventory - Taiwan) : The BFI is a 9-item self-administered questionnaire which was developed by MD Anderson Cancer Center offers assessing levels of fatigue. Subjects rate each item based on how they felt for the preceding week using a 1-10 numeric rating scale (10 being the most unfavorable response). The single construct of the BFI allows for the mean of the nine items to be the overall score. The score is categorized as mild (1-3), moderate (4-6), and severe (7-10). The scale is a reliable instrument that correlates highly with similar fatigue and performance status measures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a trial to evaluate use of PG2 for fatigue improvement in advanced cancer patients who are under standard palliative care at hospice setting and have no further curative options available. Only patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. All patients will continue the standard palliative care (SPC) during this study.

The main aim of this trial is to compare improvement of patient's fatigue status between patients with or without PG2 treatment. Patient's fatigue status will be assessed by the Brief Fatigue Inventory-Taiwanese (BFI-T) Form. Each patient's fatigue improvement response will be defined as an improvement in the mean fatigue scores by at least 10% from baseline. Other quality of life parameters will be measured by the 11 questions (SS11) of the EORTC QLQ-C30 and by Karnofsky performance scale. Patient's weight change and its related c-reactive protein will be followed. There are two study arms in this trial: 1) the PG2 plus SPC arm; and 2) the Placebo plus SPC arm.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Mackay Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed the informed consent form
  • ≧ 18 years old
  • Have locally advanced or metastatic cancer or inoperable advanced cancer
  • Under standard palliative care (SPC) at hospice setting and have no further curative options available
  • BFI fatigue score ≧ 4
  • Women with childbearing potential must use contraception
  • Life expectancy of at least 3 months as determined by the investigator
  • Willing and able to complete quality of life questionnaires

Exclusion Criteria:

  • Pregnant or breast-feeding females
  • Uncontrolled systemic disease such as active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus
  • Take central nervous system stimulators such as Methylphenidate within last 30 days
  • In other investigational drug trials within last 30 days
  • Karnofsky performance scores < 30%
  • Diagnosed as dying status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PG2
PG2 500 mg / 500 ml normal saline will be given t.i.w for 8 weeks.
Drug: PG2
PG2 500 mg / 500 ml normal saline t.i.w. per week
Placebo Comparator: Placebo
500 ml normal saline will be given t.i.w 1-4 weeks, then PG2 500 mg / 500 ml normal saline will be given 5-8 weeks.
Drug: PG2
PG2 500 mg / 500 ml normal saline t.i.w. per week
Drug: Placebo
500 ml normal saline t.i.w. per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The fatigue improvement response rate among patients between two study arms will be compared as the basis for efficacy evaluation at the end of the first treatment cycle.
Time Frame: within and between each cycle (4 weeks)
within and between each cycle (4 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
The fatigue improvement response rate among patients within and between cycles (by BFI-T)
Time Frame: within and between cycles (4 weeks)
within and between cycles (4 weeks)
The fatigue improvement by multiple BFI-T score levels among patients between two study arms
Time Frame: within and between cycles (4 weeks)
within and between cycles (4 weeks)
The mean fatigue scores change from baseline among patients within and between cycles (by BFI-T)
Time Frame: within and between cycles (4 weeks)
within and between cycles (4 weeks)
Symptoms/Quality of Life Assessments: SS11 of EORTC QLQ-C30 includes eleven questions to assess the symptoms/QoL parameters: sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life
Time Frame: within and between cycles (4 weeks)
within and between cycles (4 weeks)
Karnofsky performance score
Time Frame: within and between cycles (4 weeks)
within and between cycles (4 weeks)
Weight change and the related blood c-reactive protein level
Time Frame: within and between cycles (4 weeks)
within and between cycles (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PhytoHealth Corporation

Investigators

  • Principal Investigator: Yuen-Liang Lai, M.D., Mackay Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 21, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (Estimated)

August 30, 2007

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH-CP012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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