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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by PhytoHealth Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT00518869
First received: August 18, 2007
Last updated: June 9, 2009
Last verified: June 2009

August 18, 2007
June 9, 2009
September 2007
June 2010   (final data collection date for primary outcome measure)
  • Clinical Benefit Response [ Time Frame: within and between each chemo-cycle (21 days) ] [ Designated as safety issue: No ]
  • Incidence of Grade III plus IV Neutropenia [ Time Frame: within and between each chemo-cycle (21 days) ] [ Designated as safety issue: Yes ]
  • Clinical Benefit Response (which is a metric measurement including patient-assessed fatigue status, clinician-assessed karnofsky performance status and weight change [ Time Frame: within and between each chemo-cycle (21 days) ]
  • Incidence of Grade III plus IV Neutropenia [ Time Frame: within and between each chemo-cycle (21 days) ]
Complete list of historical versions of study NCT00518869 on ClinicalTrials.gov Archive Site
  • Quality of Life Assessments [ Time Frame: within and between each chemo-cycle (21 days) ] [ Designated as safety issue: No ]
  • The blood c-reactive protein level which is related to weight change [ Time Frame: within and between each chemo-cycle (21 days) ] [ Designated as safety issue: No ]
  • Tumor Response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Survival Time [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption [ Time Frame: within and beween each chemo-cycle (21 days) ] [ Designated as safety issue: Yes ]
  • Quality of Life Assessments [ Time Frame: within and between each chemo-cycle (21 days) ]
  • The blood c-reactive protein level which is related to weight change [ Time Frame: within and between each chemo-cycle (21 days) ]
  • Tumor Response [ Time Frame: 3 months ]
  • Survival Time [ Time Frame: one year ]
  • Incidences of myelosuppression (including neutropenia, anemia and thrombocytopenia) and the related G-CSF consumption and antibiotics consumption [ Time Frame: within and beween each chemo-cycle (21 days) ]
Not Provided
Not Provided
 
Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue
Not Provided

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Quality of Life
  • Fatigue
  • Complementary
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.
  • Experimental: Treatment group
    PG2 plus standard chemotherapies
    Intervention: Drug: PG2
  • Placebo Comparator: Placeo group
    Placebo plus standard chemotherapies
    Intervention: Drug: PG2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
December 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
17 Years to 75 Years
No
Contact: WenHan Chen 886-2-25453697 ext 333 whchen@phytohealth.com.tw
Taiwan
 
NCT00518869
PH-CP010
No
Reury-Perng Perng, M.D., Ph.D., Taipei Veterans General Hospital, Tawian
PhytoHealth Corporation
Not Provided
Study Chair: Reury-Perng Perng, M.D., Ph.D. Taipei Veterans General Hospital, Tawian
Principal Investigator: Yuh-Min Chen, M.D., Ph.D. Taipei Veterans General Hospital, Taiwan
Principal Investigator: Ying-Huang Tsai, M.D. Chang-Gung Memorial Hospital, Linkou, Taiwan
Principal Investigator: Woei-Yau Kao, M.D., Ph.D. Tri-Service General Hospital
Principal Investigator: Ruey Kuen Hsieh, M.D. Mackay Memorial Hospital
Principal Investigator: Cheng-Shyong Chang, M.D. Changhua Christian Hospital, Taiwan
Principal Investigator: Gee-Chen Chang, M.D., Ph.D. Taichung Veterans General Hospital, Taiwan
Principal Investigator: Te-Chun Hsia, M.D. China Medical University Hospital, Taiwan
Principal Investigator: Ming-Shyan Huang, M.D., Ph.D. Kaoshiung Medical University Hospital, Taiwan
Principal Investigator: Meng-Chih Lin, M.D. Chang-Gung Memorial Hospital, Kaoshiung, Taiwan
Principal Investigator: Wu-Chou Su, M.D. National Cheng-Kung University Hospital, Taiwan
PhytoHealth Corporation
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP