Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue (NCT00518869) | Clinical Trial Compass
TerminatedPhase 2/3
Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue
Stopped: Sponsor's decision
Taiwan13 participantsStarted 2007-09
Plain-language 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. 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.
Who can participate
Age range
17 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Benefit Response
Timeframe: within and between each chemo-cycle (21 days)
2
Incidence of Grade III plus IV Neutropenia
Timeframe: within and between each chemo-cycle (21 days)