Cancer-related FatiguePhase 4NCT01720550
PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
A Phase 4 study testing Astragalus Polysaccharides 500 mg and Astragalus Polysaccharides 250 mg in people with Cancer-related Fatigue, run by PhytoHealth Corporation at 9 sites in Taiwan.
Trial summary
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 different doses of PG2 treatment for relieving fatigue among advanced cancer patients who are under standard palliative care… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- Astragalus Polysaccharides 500 mg and Astragalus Polysaccharides 250 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 9 sitesTaiwan
- Study dates
- Nov 2012to Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Taiwan9 sites
Changhua Christian Hospital
Changhua, 500
Chang Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City, 833
Chang Gung Memorial Hospital, Lovers Lake Branch
Keelung, 204
China Medical University Hospital
Taichung, 404
Chi Mei Hospital, Loiuying Campus
Tainan, 736
Mackay Memorial Hospital
Taipei, 104
Tri-Service General Hospital
Taipei, 114
Taipei Medical University -Shung Ho Hospital
Taipei, 235
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
About this study
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 different doses of PG2 treatment 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(European Organization) for Research and Treatment of Cancer 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.
Read the 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.
- Conditions
- Cancer-related Fatigue
- Being tested
- Astragalus Polysaccharides 500 mg, Astragalus Polysaccharides 250 mg
- Keywords
- Cancer-related fatigue, Palliative Treatment, Astragalus polysaccharides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astragalus Polysaccharides 500 mgDrug
Also called PG2 Injection 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)
Astragalus Polysaccharides 250 mgDrug
Also called PG2 Injection 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)
| Study group | Role | What they receive |
|---|---|---|
| PG2 High Dose | Experimental | Astragalus Polysaccharides 500 mg Receives: Drug: Astragalus Polysaccharides 500 mg |
| PG2 Low Dose | Experimental | Astragalus Polysaccharides 250 mg Receives: Drug: Astragalus Polysaccharides 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Improvement Response Rate
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).
Measured: 4 weeks
Secondary outcomes (11)
The fatigue improvement response rate among patients within and between cycles (by BFI-T)
Measured: 8 weeks
The fatigue improvement by multiple BFI-T score percentage change levels among patients between two study arms
Measured: 8 weeks
The mean of patients' fatigue score change from baseline within and between cycles (by BFI-T)
Measured: 8 weeks
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)
Measured: 8 weeks
Karnofsky performance score
Measured: 8 weeks
The correlation between Weight change and the related blood c-reactive protein level
Measured: 8 weeks
Physical Examination
Measured: 8 weeks
Labolatory Safety Examination
Included hematological, biochemical and urine examination
Measured: 8 weeks
Incidence of Adverse Events as a Measure of Safety and Tolerability
Measured: 8 weeks
Vital signs
Measured: 8 weeks
Immune Biomarkers
This outcome specified for academic research was designed in add-on protocol (only submitted to IRB)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuen-Liang YL Lai, MD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720550
- Sponsor's protocol ID
- PH-CP012 (II)
- Status last verified
- Jun 2025
- First submitted
- 29 Oct 2012
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
- ClinicalTrials.gov ID
- NCT01720550
- Acronym / sponsor ID
- PH-CP012 (II)
- Conditions
- Cancer-related Fatigue
- Keywords
- Cancer-related fatigue, Palliative Treatment, Astragalus polysaccharides
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 different doses of PG2 treatment 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(European Organization) for Research and Treatment of Cancer 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PG2 High Dose | Experimental | Drug: Astragalus Polysaccharides 500 mgAstragalus Polysaccharides 500 mg |
| PG2 Low Dose | Experimental | Drug: Astragalus Polysaccharides 250 mgAstragalus Polysaccharides 250 mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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 %
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astragalus Polysaccharides 500 mgAlso: PG2 Injection 500 mgPG2 (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) | Drug | PG2 High Dose |
| Astragalus Polysaccharides 250 mgAlso: PG2 Injection 250 mgPG2 (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) | Drug | PG2 Low Dose |
Primary outcome
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).
11 secondary outcomes
The fatigue improvement response rate among patients within and between cycles (by BFI-T)
Time frame: 8 weeks
The fatigue improvement by multiple BFI-T score percentage change levels among patients between two study arms
Time frame: 8 weeks
The mean of patients' fatigue score change from baseline within and between cycles (by BFI-T)
Time frame: 8 weeks
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
Karnofsky performance score
Time frame: 8 weeks
The correlation between Weight change and the related blood c-reactive protein level
Time frame: 8 weeks
Physical Examination
Time frame: 8 weeks
Labolatory Safety Examination
Time frame: 8 weeks
Incidence of Adverse Events as a Measure of Safety and Tolerability
Time frame: 8 weeks
Vital signs
Time frame: 8 weeks
Immune Biomarkers
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuen-Liang YL Lai, MD principal investigator
Mackay Memorial Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Astragalus Polysaccharides 500 mg and Astragalus Polysaccharides 250 mg in people with Cancer-related Fatigue, run by PhytoHealth Corporation at 9 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Improvement Response Rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.