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NCT Number: NCT00523107

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

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.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mackay Memorial Hospital

New Taipei City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PG2

Drug

PG2 500 mg / 500 ml normal saline t.i.w. per week

Placebo

Drug

500 ml normal saline t.i.w. per week

Primary outcomes

  1. 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)

Secondary outcomes

  1. The fatigue improvement response rate among patients within and between cycles (by BFI-T)

    Time frame: within and between cycles (4 weeks)

  2. The fatigue improvement by multiple BFI-T score levels among patients between two study arms

    Time frame: within and between cycles (4 weeks)

  3. The mean fatigue scores change from baseline among patients within and between cycles (by BFI-T)

    Time frame: within and between cycles (4 weeks)

  4. 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)

  5. Karnofsky performance score

    Time frame: within and between cycles (4 weeks)

  6. Weight change and the related blood c-reactive protein level

    Time frame: within and between cycles (4 weeks)

Sponsors and collaborators

Lead sponsor

PhytoHealth Corporation

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 30, 2007
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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