17 Years
75 Years
Both
Quality of Life, Fatigue, Complementary
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Clinical Benefit Response
Outcome Time Frame:
within and between each chemo-cycle (21 days)
Safety Issue:
No
Principal Investigator
Reury-Perng Perng, M.D., Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Taipei Veterans General Hospital, Tawian
Authority:
Taiwan: Institutional Review Board
Study ID:
PH-CP010
NCT ID:
NCT00518869
Start Date:
September 2007
Completion Date:
December 2010
Related Keywords:
- Quality of Life
- Fatigue
- Complementary
- Non-Small Cell Lung Cancer (NSCLC)
- Complementary and Alternative Medicine (CAM)
- Chemotherapy
- Myelosuppression
- Quality of Life
- Fatigue
- EORTC QLQ-C30 and LC13
- Fatigue
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