FatiguePhase 2/3NCT00523107
PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
A Phase 2/3 study testing PG2 in people with Fatigue, run by PhytoHealth Corporation at 1 site 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 PG2 for relieving fatigue among advanced cancer patients who are under standard palliative care (SPC) at hospice setting and have… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fatigue
- What is being tested?
- PG2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2007to Apr 2008
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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 PG2 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 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.
- BFI-T (Brief Fatigue Inventory - Taiwan) : The BFI is a 9-item self-administered questionnaire which was developed by MD Anderson Cancer Center offers assessing levels of fatigue. Subjects rate each item based on how they felt for the preceding week using a 1-10 numeric rating scale (10 being the most unfavorable response). The single construct of the BFI allows for the mean of the nine items to be the overall score. The score is categorized as mild (1-3), moderate (4-6), and severe (7-10). The scale is a reliable instrument that correlates highly with similar fatigue and performance status measures.
Read the detailed description
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.
- Conditions
- Fatigue
- Being tested
- PG2, Placebo
- Keywords
- Fatigue, Standard Palliative Care, PG2, QLQ-C30, Compassionate
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG2Drug
PG2 500 mg / 500 ml normal saline t.i.w. per week
PlaceboDrug
500 ml normal saline t.i.w. per week
| Study group | Role | What they receive |
|---|---|---|
| PG2 | Experimental | PG2 500 mg / 500 ml normal saline will be given t.i.w for 8 weeks. Receives: Drug: PG2 |
| Placebo | Placebo comparator | 500 ml normal saline will be given t.i.w 1-4 weeks, then PG2 500 mg / 500 ml normal saline will be given 5-8 weeks. Receives: Drug: PG2; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within and between each cycle (4 weeks)
Secondary outcomes (6)
The fatigue improvement response rate among patients within and between cycles (by BFI-T)
Measured: within and between cycles (4 weeks)
The fatigue improvement by multiple BFI-T score levels among patients between two study arms
Measured: within and between cycles (4 weeks)
The mean fatigue scores change from baseline among patients within and between cycles (by BFI-T)
Measured: within and between cycles (4 weeks)
Symptoms/Quality of Life Assessments: SS11 of EORTC QLQ-C30 includes eleven questions to assess the symptoms/QoL parameters: sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life
Measured: within and between cycles (4 weeks)
Karnofsky performance score
Measured: within and between cycles (4 weeks)
Weight change and the related blood c-reactive protein level
Measured: within and between cycles (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuen-Liang Lai, M.D., Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523107
- Sponsor's protocol ID
- PH-CP012
- Status last verified
- Jun 2025
- First submitted
- 21 Aug 2007
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
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
- NCT00523107
- Acronym / sponsor ID
- PH-CP012
- Conditions
- Fatigue
- Keywords
- Fatigue, Standard Palliative Care, PG2, QLQ-C30, Compassionate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2007 (actual)
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 30 Aug 2007 (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 PG2 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 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.
- BFI-T (Brief Fatigue Inventory - Taiwan) : The BFI is a 9-item self-administered questionnaire which was developed by MD Anderson Cancer Center offers assessing levels of fatigue. Subjects rate each item based on how they felt for the preceding week using a 1-10 numeric rating scale (10 being the most unfavorable response). The single construct of the BFI allows for the mean of the nine items to be the overall score. The score is categorized as mild (1-3), moderate (4-6), and severe (7-10). The scale is a reliable instrument that correlates highly with similar fatigue and performance status measures.
Detailed description
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.
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 | Experimental | Drug: PG2PG2 500 mg / 500 ml normal saline will be given t.i.w for 8 weeks. |
| Placebo | Placebo comparator | Drug: PG2, Drug: Placebo500 ml normal saline will be given t.i.w 1-4 weeks, then PG2 500 mg / 500 ml normal saline will be given 5-8 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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%
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 |
|---|---|---|
| PG2PG2 500 mg / 500 ml normal saline t.i.w. per week | Drug | PG2, Placebo |
| Placebo500 ml normal saline t.i.w. per week | Drug | Placebo |
Primary outcome
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.
Time frame: within and between each cycle (4 weeks)
6 secondary outcomes
The fatigue improvement response rate among patients within and between cycles (by BFI-T)
Time frame: within and between cycles (4 weeks)
The fatigue improvement by multiple BFI-T score levels among patients between two study arms
Time frame: within and between cycles (4 weeks)
The mean fatigue scores change from baseline among patients within and between cycles (by BFI-T)
Time frame: within and between cycles (4 weeks)
Symptoms/Quality of Life Assessments: SS11 of EORTC QLQ-C30 includes eleven questions to assess the symptoms/QoL parameters: sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life
Time frame: within and between cycles (4 weeks)
Karnofsky performance score
Time frame: within and between cycles (4 weeks)
Weight change and the related blood c-reactive protein level
Time frame: within and between cycles (4 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.
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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 Lai, M.D. principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PG2 in people with Fatigue, run by PhytoHealth Corporation at 1 site 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 8 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 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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. (time frame: within and between each cycle (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.