Quality of LifePhase 2/3NCT00518869
Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue
A Phase 2/3 study testing PG2 in people with Quality of Life and Fatigue, run by PhytoHealth Corporation at 10 sites in Taiwan.
Trial summary
The objective of this study is to evaluate the efficacy and safety of PG2 as a complementary treatment to conventional chemotherapy among NSCLC patients. In reference to previous studies, "Clinical Benefit Response" and "Incidence of Grade III plus VI Neutropenia" will be used as the primary endpoints in this study. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Quality of Life, Fatigue, Complementary
- What is being tested?
- PG2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 10 sitesTaiwan
- Study dates
- Sep 2007to Dec 2009
- 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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed the informed consent form.
- 18 ~ 75 years old
- Locally advanced or metastatic with inoperable stage IIIb-IV non-small-cell lung cancer.
- Chemo/Radio naive patient
- Karnofsky Performance Scores ≧ 70.
- Adequate bone marrow reserve.
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- Adequate liver function.
- Adequate renal function.
- Women with childbearing potential are willing to take contraception measures through the whole treatment course.
- Life expectancy ≧ 3 months
- Patient must be willing and able to complete quality of life questionnaires.
Who cannot join
- Female patients are pregnant or breast-feeding
- Patients have brain metastases, stroke or major psychiatric disease.
- Patients with uncontrolled systemic disease such as active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus.
- Patients have enrolled or have not yet completed other investigational drug trials within 30 days before randomization.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Taiwan10 sites
Changhua Christian Hospital
Changhua
Chang-Gung Memorial Hospital - Kaoshiung
Kaohsiung City
Kaoshiung Medical University Hospital
Kaohsiung City
Chang-Gung Memorial Hospital, Linkou
Linkou District
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Cheng-Kung University Hospital
Tainan
Mackay Memorial Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
About this study
The objective of this study is to evaluate the efficacy and safety of PG2 as a complementary treatment to conventional chemotherapy among NSCLC patients. In reference to previous studies, "Clinical Benefit Response" and "Incidence of Grade III plus VI Neutropenia" will be used as the primary endpoints in this study. Clinical Benefit Response is a metric measurement including change in cancer or cancer treatment related "fatigue" which is related to chronic fatigue syndrome (CFS), change in karnofsky performance status and change in weight. The secondary endpoints include patient's global quality of life, and the blood c-reactive protein level which is related to weight change, tumor response, survival time, incidences of myelosuppression (including neutropenia, anemia and thrombocytopenia) and the related G-CSF and antibiotics consumption.
Read the detailed description
This is a multi-center, double-blind, randomized and placebo-controlled study to evaluate complementary effect of PG2 in patients with advanced non-small-cell lung cancer under conventional chemotherapy. Patients with Stage IIIb-IV non-small-cell lung cancer will be screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.
All enrolled patients will be randomized to PG2 or Placebo arm and will receive the cisplatin-based chemotherapy treatment (Cisplatin 75mg/m2 and Docetaxel 60mg/m2 on Day1) during the first three 21-day chemo-cycles. Chemo regimen modification is allowable, as usual, in case of disease progression or unacceptable toxicity (see Section 6). After randomization, each patient will be administered with PG2 or placebo for 4 days in the 1st week, 3 days in the 2nd week and 3 days in the 3rd week of each chemo-cycle for 3 cycles (Dosing Schedule in Section 6). Total 10 doses will be given in each cycle.
- Conditions
- Quality of Life, Fatigue, Complementary
- Being tested
- PG2
- Keywords
- Non-Small Cell Lung Cancer (NSCLC), Complementary and Alternative Medicine (CAM), Chemotherapy, Myelosuppression, Quality of Life, Fatigue, EORTC QLQ-C30 and LC13
- Medical subject headings
- Fatigue, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG2Drug
500 mg PG2 / 500 ml normal saline IV infusion for 3 hours once daily for 4 doses in the 1st week, 3 doses in the 2nd week and 3 doses in the 3rd week of each chemo-cycle for three cycles. Total 10 doses will be given in each cycle even with skip days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | PG2 plus standard chemotherapies Receives: Drug: PG2 |
| Placeo group | Placebo comparator | Placebo plus standard chemotherapies Receives: Drug: PG2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Response
Measured: within and between each chemo-cycle (21 days)
Incidence of Grade III plus IV Neutropenia
Measured: within and between each chemo-cycle (21 days)
Secondary outcomes (5)
Quality of Life Assessments
Measured: within and between each chemo-cycle (21 days)
The blood c-reactive protein level which is related to weight change
Measured: within and between each chemo-cycle (21 days)
Tumor Response
Measured: 3 months
Survival Time
Measured: one year
Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption
Measured: within and beween each chemo-cycle (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2008
- Study completionDec 2009
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518869
- Sponsor's protocol ID
- PH-CP010
- Status last verified
- Jun 2025
- First submitted
- 18 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
- Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue
- ClinicalTrials.gov ID
- NCT00518869
- Acronym / sponsor ID
- PH-CP010
- Conditions
- Quality of Life, Fatigue, Complementary
- Keywords
- Non-Small Cell Lung Cancer (NSCLC), Complementary and Alternative Medicine (CAM), Chemotherapy, Myelosuppression, Quality of Life, Fatigue, EORTC QLQ-C30 and LC13
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2007 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 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 evaluate the efficacy and safety of PG2 as a complementary treatment to conventional chemotherapy among NSCLC patients. In reference to previous studies, "Clinical Benefit Response" and "Incidence of Grade III plus VI Neutropenia" will be used as the primary endpoints in this study. Clinical Benefit Response is a metric measurement including change in cancer or cancer treatment related "fatigue" which is related to chronic fatigue syndrome (CFS), change in karnofsky performance status and change in weight. The secondary endpoints include patient's global quality of life, and the blood c-reactive protein level which is related to weight change, tumor response, survival time, incidences of myelosuppression (including neutropenia, anemia and thrombocytopenia) and the related G-CSF and antibiotics consumption.
Detailed description
This is a multi-center, double-blind, randomized and placebo-controlled study to evaluate complementary effect of PG2 in patients with advanced non-small-cell lung cancer under conventional chemotherapy. Patients with Stage IIIb-IV non-small-cell lung cancer will be screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.
All enrolled patients will be randomized to PG2 or Placebo arm and will receive the cisplatin-based chemotherapy treatment (Cisplatin 75mg/m2 and Docetaxel 60mg/m2 on Day1) during the first three 21-day chemo-cycles. Chemo regimen modification is allowable, as usual, in case of disease progression or unacceptable toxicity (see Section 6). After randomization, each patient will be administered with PG2 or placebo for 4 days in the 1st week, 3 days in the 2nd week and 3 days in the 3rd week of each chemo-cycle for 3 cycles (Dosing Schedule in Section 6). Total 10 doses will be given in each cycle.
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 |
|---|---|---|
| Treatment group | Experimental | Drug: PG2PG2 plus standard chemotherapies |
| Placeo group | Placebo comparator | Drug: PG2Placebo plus standard chemotherapies |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Signed the informed consent form.
- 18 ~ 75 years old
- Locally advanced or metastatic with inoperable stage IIIb-IV non-small-cell lung cancer.
- Chemo/Radio naive patient
- Karnofsky Performance Scores ≧ 70.
Key exclusion criteria (4 listed)
- Female patients are pregnant or breast-feeding
- Patients have brain metastases, stroke or major psychiatric disease.
- Patients with uncontrolled systemic disease such as active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus.
- Patients have enrolled or have not yet completed other investigational drug trials within 30 days before randomization.
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 |
|---|---|---|
| PG2500 mg PG2 / 500 ml normal saline IV infusion for 3 hours once daily for 4 doses in the 1st week, 3 doses in the 2nd week and 3 doses in the 3rd week of each chemo-cycle for three cycles. Total 10 doses will be given in each cycle even with skip days. | Drug | Placeo group, Treatment group |
Primary outcome
Clinical Benefit Response
Time frame: within and between each chemo-cycle (21 days)
Incidence of Grade III plus IV Neutropenia
Time frame: within and between each chemo-cycle (21 days)
5 secondary outcomes
Quality of Life Assessments
Time frame: within and between each chemo-cycle (21 days)
The blood c-reactive protein level which is related to weight change
Time frame: within and between each chemo-cycle (21 days)
Tumor Response
Time frame: 3 months
Survival Time
Time frame: one year
Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption
Time frame: within and beween each chemo-cycle (21 days)
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites 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 Quality of Life and Fatigue, run by PhytoHealth Corporation at 10 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 11 inclusion and 4 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: stopped early, 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 10 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. 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 was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
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?
Clinical Benefit Response (time frame: within and between each chemo-cycle (21 days)). The study lists 2 primary outcomes in all. 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.