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

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Fatigue; Complementary
• Intervention / Treatment: Drug: PG2

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; PG2 plus standard chemotherapies	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.
Placebo Comparator: Placeo group; Placebo plus standard chemotherapies	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Benefit Response	within and between each chemo-cycle (21 days)
Incidence of Grade III plus IV Neutropenia	within and between each chemo-cycle (21 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of Life Assessments	within and between each chemo-cycle (21 days)
The blood c-reactive protein level which is related to weight change	within and between each chemo-cycle (21 days)
Tumor Response	3 months
Survival Time	one year
Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption	within and beween each chemo-cycle (21 days)

Collaborators and Investigators

• Sponsor: PhytoHealth Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 18, 2007
• First Submitted That Met QC Criteria: August 20, 2007
• First Posted (Estimated): August 21, 2007

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Complementary and Alternative Medicine (CAM); Fatigue; Chemotherapy; Non-Small Cell Lung Cancer (NSCLC); Myelosuppression; EORTC QLQ-C30 and LC13
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: PH-CP010