Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 10
- 主要终点
- Clinical Benefit Response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≧
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment group
PG2 plus standard chemotherapies
干预措施: PG2 (Drug)
Placeo group
Placebo plus standard chemotherapies
干预措施: PG2 (Drug)
结局指标
主要结局
Clinical Benefit Response
时间窗: within and between each chemo-cycle (21 days)
Incidence of Grade III plus IV Neutropenia
时间窗: within and between each chemo-cycle (21 days)
次要结局
- Tumor Response(3 months)
- Survival Time(one year)
- The blood c-reactive protein level which is related to weight change(within and between each chemo-cycle (21 days))
- Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption(within and beween each chemo-cycle (21 days))
- Quality of Life Assessments(within and between each chemo-cycle (21 days))