PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
20 Years
N/A
Both
Cancer-related Fatigue
Trial Information
PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
This is a trial to evaluate use of different doses of PG2 treatment 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 different doses of 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 High Dose arm; and 2) the PG2 Low Dose arm.
Inclusion Criteria:
- Signed the informed consent form
- ≧ 20 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 score ≧ 4
- 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
- Uncontrolled systemic disease
- Take central nervous system stimulators within 30 days before screening
- Have enrolled or have not yet completed other investigational drug trials within 30
days before screening
- Karnofsky Performance Scores less than 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:
Fatigue Improvement Response Rate
Outcome Description:
Patient's fatigue status will be measured by the Brief Fatigue Inventory-Taiwanese Form (BFI-T). 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 (4th week).
Outcome Time Frame:
4 weeks
Safety Issue:
No
Principal Investigator
Yuen-Liang YL Lai, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mackay Memorial Hospital
Authority:
Taiwan : Food and Drug Administration
Study ID:
PH-CP012 (II)
NCT ID:
NCT01720550
Start Date:
November 2012
Completion Date:
April 2014
Related Keywords:
- Cancer-Related Fatigue
- Cancer-related fatigue
- Palliative Treatment
- Astragalus polysaccharides
- Fatigue
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