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

NCT00518869 | Terminated Phase 2

• 1 other identifier: PH-CP010
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Quality of Life; Fatigue; Complementary

Keywords

Non-Small Cell Lung Cancer (NSCLC); Complementary and Alternative Medicine (CAM); Chemotherapy; Myelosuppression; Quality of Life; Fatigue; EORTC QLQ-C30 and LC13

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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)

Study Arms (2)

Treatment group

EXPERIMENTAL

PG2 plus standard chemotherapies

Drug: PG2

Placeo group

PLACEBO COMPARATOR

Placebo plus standard chemotherapies

Drug: PG2

Interventions

PG2 DRUG

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.

Placeo group; Treatment group

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the informed consent form.
• \~ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (10)

Changhua Christian Hospital

Changhua, Taiwan

Location

Chang-Gung Memorial Hospital - Kaoshiung

Kaohsiung City, Taiwan

Location

Kaoshiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Chang-Gung Memorial Hospital, Linkou

Linkou District, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng-Kung University Hospital

Tainan, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Fatigue; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2007
• First Posted: August 21, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2009
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

TW (10)