Clinical trial NCT00518869: Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
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
Lead sponsor: PhytoHealth Corporation
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 13
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical Benefit Response
timeFrame: within and between each chemo-cycle (21 days)
measure: Incidence of Grade III plus IV Neutropenia
timeFrame: within and between each chemo-cycle (21 days)
Secondary outcomes:
measure: Quality of Life Assessments
timeFrame: within and between each chemo-cycle (21 days)
measure: The blood c-reactive protein level which is related to weight change
timeFrame: within and between each chemo-cycle (21 days)
measure: Tumor Response
timeFrame: 3 months
measure: Survival Time
timeFrame: one year
measure: Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption
timeFrame: within and beween each chemo-cycle (21 days)
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chang-Gung Memorial Hospital - Kaoshiung
city: Kaohsiung
country: Taiwan
facility: Kaoshiung Medical University Hospital
city: Linkou
country: Taiwan
facility: Chang-Gung Memorial Hospital, Linkou
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References: