- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01720550
PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Changhua, Taiwan, 500
- Changhua Christian Hospital
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Kaohsiung City, Taiwan, 833
- Chang gung memorial hospital, Kaohsiung branch
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Keelung, Taiwan, 204
- Chang Gung Memorial Hospital, Lakeview Branch
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Taichung, Taiwan, 404
- China Medical University Hospital
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Tainan, Taiwan, 736
- Chi Mei Hospital, Loiuying Campus
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Taipei, Taiwan, 104
- Mackay Memorial Hospital
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Taipei, Taiwan, 114
- Tri-Service General Hospital
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Taipei, Taiwan, 235
- Taipei Medical University -Shung Ho Hospital
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital, Linkou
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
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 High Dose
Astragalus Polysaccharides 500 mg
|
PG2 (500 mg in 500 ml saline), t.i.w.
via i.v.
infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
Other Names:
|
Experimental: PG2 Low Dose
Astragalus Polysaccharides 250 mg
|
PG2 (500 mg in 500 ml saline), t.i.w.
via i.v.
infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue Improvement Response Rate
Time Frame: 4 weeks
|
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).
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The fatigue improvement response rate among patients within and between cycles (by BFI-T)
Time Frame: 8 weeks
|
8 weeks
|
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The fatigue improvement by multiple BFI-T score percentage change levels among patients between two study arms
Time Frame: 8 weeks
|
8 weeks
|
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The mean of patients' fatigue score change from baseline within and between cycles (by BFI-T)
Time Frame: 8 weeks
|
8 weeks
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Symptoms and Quality of Life Assessments: SS11 from EORTC QLQ-C30 (including the evaluation of the quality of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life)
Time Frame: 8 weeks
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8 weeks
|
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Karnofsky performance score
Time Frame: 8 weeks
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8 weeks
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The correlation between Weight change and the related blood c-reactive protein level
Time Frame: 8 weeks
|
8 weeks
|
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Physical Examination
Time Frame: 8 weeks
|
8 weeks
|
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Labolatory Safety Examination
Time Frame: 8 weeks
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Included hematological, biochemical and urine examination
|
8 weeks
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Incidence of Adverse Events as a Measure of Safety and Tolerability
Time Frame: 8 weeks
|
8 weeks
|
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Vital signs
Time Frame: 8 weeks
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8 weeks
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Immune Biomarkers
Time Frame: 8 weeks
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This outcome specified for academic research was designed in add-on protocol (only submitted to IRB)
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yuen-Liang YL Lai, MD, Mackay Memorial Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PH-CP012 (II)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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