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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.
within and between each cycle (4 weeks)
Yuen-Liang Lai, M.D.
Mackay Memorial Hospital
Taiwan: Department of Health