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

Primary Purpose

Quality of Life, Fatigue, Complementary

Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
PG2
Sponsored by
PhytoHealth Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring Non-Small Cell Lung Cancer (NSCLC), Complementary and Alternative Medicine (CAM), Chemotherapy, Myelosuppression, Quality of Life, Fatigue, EORTC QLQ-C30 and LC13

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Placeo group

Arm Description

PG2 plus standard chemotherapies

Placebo plus standard chemotherapies

Outcomes

Primary Outcome Measures

Clinical Benefit Response
Incidence of Grade III plus IV Neutropenia

Secondary Outcome Measures

Quality of Life Assessments
The blood c-reactive protein level which is related to weight change
Tumor Response
Survival Time
Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption

Full Information

First Posted
August 18, 2007
Last Updated
June 13, 2022
Sponsor
PhytoHealth Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00518869
Brief Title
Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision
Study Start Date
September 2007 (Actual)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
PhytoHealth Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
PG2 plus standard chemotherapies
Arm Title
Placeo group
Arm Type
Placebo Comparator
Arm Description
Placebo plus standard chemotherapies
Intervention Type
Drug
Intervention Name(s)
PG2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Benefit Response
Time Frame
within and between each chemo-cycle (21 days)
Title
Incidence of Grade III plus IV Neutropenia
Time Frame
within and between each chemo-cycle (21 days)
Secondary Outcome Measure Information:
Title
Quality of Life Assessments
Time Frame
within and between each chemo-cycle (21 days)
Title
The blood c-reactive protein level which is related to weight change
Time Frame
within and between each chemo-cycle (21 days)
Title
Tumor Response
Time Frame
3 months
Title
Survival Time
Time Frame
one year
Title
Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption
Time Frame
within and beween each chemo-cycle (21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital - Kaoshiung
City
Kaoshiung
Country
Taiwan
Facility Name
Kaoshiung Medical University Hospital
City
Kaoshiung
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, Linkou
City
Linkou
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng-Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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

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