The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 322
- 主要终点
- Change From Baseline to Week 4 in the General Subscale of the MFSI-SF
研究概览
简要总结
RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known whether American ginseng is more effective than a placebo in treating cancer-related fatigue.
PURPOSE: This randomized phase III trial is studying American ginseng to see how well it works in treating patients with fatigue caused by cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of American ginseng (Panax quinquefolius) as therapy for cancer-related fatigue as measured by the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF).
Secondary
- To evaluate toxicities and tolerability of American ginseng when used for cancer-related fatigue.
- To examine stress as a mediating variable on the effects of American ginseng on cancer-related fatigue.
- To explore the impact of American ginseng on various dimensions of fatigue as measured by the other subscales of the MFSI-SF, functional interference as measured by the Brief Fatigue Inventory (BFI), stress as measured by the Perceived Stress Scale, and well being as measured by the Profile of Mood States (POMS), as well as the single measure of fatigue.
- To determine clinically significant changes in fatigue scores using the global impression of change.
- To evaluate whether there are differences in the efficacy of American ginseng for fatigue based on minority populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.
干预措施: American ginseng (Drug)
Arm II
Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.
干预措施: placebo (Other)
结局指标
主要结局
Change From Baseline to Week 4 in the General Subscale of the MFSI-SF
时间窗: Baseline and week 4
Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
次要结局
- Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue(Baseline and Week 4)
- Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS(Baseline and Week 4)
- Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)(Baseline and Week 4)
- Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue(Baseline and Week 8)
- Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS(Baseline and week 8)
- Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)(Baseline and Week 8)
- Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence(Week 1 to Week 8)
- Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF(Baseline and Week 4)
- Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3(Baseline and Week 8)
- Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF(Baseline and week 8)
- Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3(Baseline and Week 4)
- Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations(Baseline and Week 4)