Effects of PG2 on Fatigue-Related Symptom Clusters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale
研究概览
简要总结
This study is for an "add-on" study to the "main" study (Protocol No.: PH-CP012). The information of patients from main study will be collected by questionnaire survey and actigraphy measurement to evaluate the relationship between fatigue, depression and sleep disorder and the efficacy of PG2 after treatment.The association between symptom cluster and circadian rhythm will be also further explored.
详细描述
The study is "PG2 Treatment for Improving Fatigue among Advanced Cancer Patients under Standard Palliative Care" (Protocol Number: PH-CP012) of the additional plan, through questionnaires and using actigraphy measuring circadian rhythm collect patient data master plans, assessed for "PG2" treatment of cancer patients before and after treatment fatigue, depression, sleep disorders and other related symptoms of resistance and the effectiveness of treatment, and to further explore the symptom clusters in cancer patients associated with the circadian rhythm
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who signed the informed consent form
- •The age of eligible patients should be 20 years old.
- •Eligible patients must have locally advanced or metastatic cancer or inoperable advanced cancer.
- •Patients are under standard palliative care (SPC) at hospice setting and have no further curative options available.
- •Patients with BFI fatigue score 4 during screening.
- •Patients have a life expectancy of at least 3 months as determined by the investigator.
- •Patient must be willing and able to complete quality of life questionnaires.
排除标准
- •Female patients are pregnant or breast-feeding.
- •Patients with uncontrolled systemic disease such as active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus.
- •Patients take central nervous system stimulators such as Methylphenidate within 30 days before screening.
- •Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening.
- •Patients with Karnofsky Performance Scores less than 30 % at time of screening
- •Patients who are diagnosed as dying status
研究组 & 干预措施
Astragalus Polysaccharides 500 mg
PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
干预措施: Astragalus Polysaccharides 500 mg (Drug)
Astragalus Polysaccharides 250 mg
PG2 (250 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
干预措施: Astragalus Polysaccharides 250 mg (Drug)
结局指标
主要结局
Hospital Anxiety and Depression Scale
时间窗: about 5-10 minutes
Pittsburgh Sleep Quality Scale
时间窗: about 5-10 minutes
Actigraphy measuring circadian rhythm
时间窗: 3-month course of treatment, a total of three measurements, each measurement 7 days
three measurements means:3 days prior to the first dose of study medication began wearing courses of the last visits to the first week; last treatment of 3rd and 7th weeks of medication visits began wearing last time between the 4th and 8th week of visits
次要结局
未报告次要终点
研究者
Chia-Chin Lin
Dean
Taipei Medical University