Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PhytoHealth Corporation

Criteria

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.