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

Quality of Life Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00518869
• Other study ID #: PH-CP010
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: November 2023
• Source: PhytoHealth Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complementary
• Fatigue
• Quality of Life

Intervention

Drug:
• PG2
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.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Chang-Gung Memorial Hospital - Kaoshiung	Kaohsiung
Taiwan	Kaoshiung Medical University Hospital	Kaohsiung
Taiwan	Chang-Gung Memorial Hospital, Linkou	Linkou
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng-Kung University Hospital	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
PhytoHealth Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Benefit Response		within and between each chemo-cycle (21 days)
Primary	Incidence of Grade III plus IV Neutropenia		within and between each chemo-cycle (21 days)
Secondary	Quality of Life Assessments		within and between each chemo-cycle (21 days)
Secondary	The blood c-reactive protein level which is related to weight change		within and between each chemo-cycle (21 days)
Secondary	Tumor Response		3 months
Secondary	Survival Time		one year
Secondary	Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption		within and beween each chemo-cycle (21 days)