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
  Purpose

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.


Condition Intervention Phase
Quality of Life
Fatigue
Complementary
Drug: PG2
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by PhytoHealth Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 210
Study Start Date: September 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   17 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518869

Contacts
Contact: WenHan Chen 886-2-25453697 ext 333 whchen@phytohealth.com.tw

Locations
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan
Principal Investigator: Cheng-Shyong Chang, M.D.         
Sub-Investigator: Ming-Lin Ho, M.D.         
Chang-Gung Memorial Hospital - Kaoshiung Recruiting
Kaoshiung, Taiwan
Principal Investigator: Meng-Chih Lin, M.D.         
Sub-Investigator: Yi-Hsi Wang, M.D.         
Kaoshiung Medical University Hospital Recruiting
Kaoshiung, Taiwan
Principal Investigator: Ming-Shyan Huang, M.D., Ph.D.         
Sub-Investigator: Jen-Yu Hung, M.D.         
Chang-Gung Memorial Hospital, Linkou Recruiting
Linkou, Taiwan
Principal Investigator: Ying-Huang Tsai, M.D.         
China Medical University Hospital Recruiting
Taichung, Taiwan
Principal Investigator: Te-Chun Hsia, M.D.         
Sub-Investigator: Jian-Jung Chen, M.D., Ph.D.         
Sub-Investigator: Hung-Jen Chen, M.D.         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
Principal Investigator: Gee-Chen Chang, M.D., Ph.D.         
Sub-Investigator: Tsung-Ying Yang, M.D.         
National Cheng-Kung University Hospital Recruiting
Tainan, Taiwan
Principal Investigator: Wu-Chou Su, M.D.         
Mackay Memorial Hospital Recruiting
Taipei, Taiwan
Principal Investigator: Ruey Kuen Hsieh, M.D.         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Principal Investigator: Yuh-Min Chen, M.D., Ph.D.         
Principal Investigator: Reury-Perng Perng, M.D., Ph.D.         
Tri-Service General Hospital Not yet recruiting
Taipei, Taiwan
Principal Investigator: Woei-Yau Kao, M.D., Ph.D.         
Principal Investigator: Tsu-Yi Chao, M.D., Ph.D.         
Sub-Investigator: Yeu-Chin Chen, M.D.         
Sub-Investigator: Nai-Shun Yao, M.D.         
Sub-Investigator: Ching-Liang Ho, M.D.         
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Reury-Perng Perng, M.D., Ph.D., Taipei Veterans General Hospital, Tawian
ClinicalTrials.gov Identifier: NCT00518869     History of Changes
Other Study ID Numbers: PH-CP010
Study First Received: August 18, 2007
Last Updated: June 9, 2009
Health Authority: Taiwan: Institutional Review Board
Taiwan: Department of Health

Keywords provided by PhytoHealth Corporation:
Non-Small Cell Lung Cancer (NSCLC)
Complementary and Alternative Medicine (CAM)
Chemotherapy
Myelosuppression
Quality of Life
Fatigue
EORTC QLQ-C30 and LC13

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014