PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
N/A
N/A
Both
Fatigue
Trial Information
PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
within and between each cycle (4 weeks)
Principal Investigator
Yuen-Liang Lai, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mackay Memorial Hospital
Authority:
Taiwan: Department of Health
Study ID:
PH-CP012
NCT ID:
NCT00523107
Start Date:
August 2007
Completion Date:
April 2008
Related Keywords:
- Fatigue
- Fatigue
- Standard Palliative Care
- PG2
- QLQ-C30
- Compassionate
- Fatigue
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