The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 主要终点
- Fatigue by brief inventory at 4 and 8 weeks of treatment
研究概览
简要总结
RATIONALE: American ginseng may help relieve cancer-related fatigue.
PURPOSE: This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of American ginseng, administered at 3 different doses, vs placebo in patients with cancer-related fatigue.
Secondary
- Determine the toxic effects and tolerability of American ginseng in these patients.
- Determine the impact of American ginseng on quality of life-related variables (e.g., sleep, vitality, and quality of life domains) in these patients.
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed cancer
- •Experiences cancer-related fatigue, defined as a baseline fatigue score of ≥ 4 on a numerical analogue scale (0-10)
- •Fatigue must be present for ≥ 1 month before study entry
- •No primary brain cancer, brain metastases, or other CNS malignancy, including CNS lymphoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Hemoglobin ≥ 11 g/dL
- •SGOT ≤ 1.5 times upper limit of normal (ULN)
- •Calcium ≤ 1.2 times ULN
- •Creatinine ≤ 1.2 times ULN
- •Cardiovascular
- •No uncontrolled hypertension (i.e., diastolic blood pressure [BP] > 100 mm Hg and/or systolic BP > 160)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No diabetes, defined as receiving oral hypoglycemics or insulin
- •No hypersensitivity to ginseng
- •No uncontrolled pain, hypothyroidism, or insomnia that is considered to be the primary cause of patient's fatigue
- •Not currently under the care of a psychiatrist for documented psychiatric disorder (e.g., severe depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Concurrent epoetin alfa for treatment of anemia allowed
- •Chemotherapy
- •Concurrent chemotherapy allowed except CHOP therapy
- •Endocrine therapy
- •No concurrent chronic systemic steroids
- •Radiotherapy
- •Not specified
- •More than 4 weeks since prior major surgery
- •No prior ginseng capsules for fatigue
- •Prior ginseng-containing teas or drinks purchased at a grocery store allowed
- •No concurrent pharmacologic agents for the treatment of fatigue, including any of the following:
- •Psychostimulants
- •Antidepressants
- •Antidepressants used to treat conditions other than fatigue (e.g., hot flashes) are allowed provided the patient has been on a stable dose for ≥ 1 month and plans to continue antidepressant for ≥ 1 month
- •No concurrent monoamine oxidase inhibitors
- •No concurrent full anticoagulation doses of warfarin or heparin
- •A dose of 1 mg/day for preventing catheter clots allowed
排除标准
- 未提供
研究组 & 干预措施
Arm III - American ginseng (high-dose)
Patients receive oral American ginseng at the high dose twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study.
干预措施: American ginseng (Dietary Supplement)
Arm IV - Placebo
Patients receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study.
干预措施: Placebo (Other)
Arm II - American ginseng (mid-dose)
Patients receive oral American ginseng at the mid-dose twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study.
干预措施: American ginseng (Dietary Supplement)
Arm I - American ginseng (low dose)
Patients receive oral American ginseng twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study.
Quality of life is assessed at baseline, every 2 weeks during treatment, and at the end of treatment.
PROJECTED ACCRUAL: A total of 280 patients (70 per treatment arm) will be accrued for this study within 35 months.
干预措施: American ginseng (Dietary Supplement)
结局指标
主要结局
Fatigue by brief inventory at 4 and 8 weeks of treatment
时间窗: at 4 and 8 weeks
次要结局
- Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment(at 4 and 8 weeks)
- Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment(at 4 and 8 weeks)