drugset / Trial / NCT00518869

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

NCT00518869 ↗

Phase 2/3 Terminated 13 enrolled PhytoHealth Corporation
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-09
Primary completion
2008-06
Completion
2009-12

Outcome

Outcome not reported

Stopped: “Sponsor's decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject PG2 Unknown 500 mg Intravenous

Indications

No indication recorded.