NCT00752895已完成2 期
A Randomized, Double-Blind, Placebo Controlled Trial of North American Ginseng Extract (CVT-E002; COLD-fX®) to Prevent Respiratory Infection and Reduce Antibiotic Use in Patients With Chronic Lymphocytic Leukemia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 125
- 主要终点
- Acute Respiratory Infection (ARI) Days
研究概览
简要总结
RATIONALE: American ginseng extract may prevent or reduce acute respiratory illness in patients with chronic lymphocytic leukemia. It is not yet known whether American ginseng extract is more effective than a placebo in preventing respiratory infections.
PURPOSE: This randomized trial is studying the side effects of American ginseng extract and to see how well it works compared with a placebo in preventing respiratory infection and in reducing antibiotic use in patients with chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- To assess the effect of American ginseng extract on the number of days of acute respiratory infection (ARI) during the peak respiratory illness season (January-March) in patients with chronic lymphocytic leukemia (CLL).
- To determine the safety of American ginseng extract in these patients evaluated according to NCI CTCAE v3.0.
Secondary
- To assess the effect of this treatment on antibiotic use days (AUDs).
- To assess the effect of this treatment on the rate of all infections diagnosed by a physician.
- To assess the effect of this treatment on the duration and severity of each ARI episode.
- To assess the effect of this treatment on major infections defined as infection severe enough to require hospitalization or intravenous antibiotics.
- To assess the effect of this treatment on the incidence of herpes zoster infection defined as an episode of physician-diagnosed zoster infection.
- To assess the effect of this treatment on CLL disease activity (i.e., serum IgG, total lymphocyte count, platelet count, and Rai staging).
- To determine the incidence of ARI and type of illness in an untreated cohort of CLL patients over an entire winter respiratory illness season (January 1- April 30).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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:
- •Diagnosis of chronic lymphocytic leukemia (CLL)
- •Phenotypic evidence (i.e., flow cytometry or bone marrow biopsy) of disease
- •Untreated CLL allowed
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •Life expectancy > 12 months
- •Creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min
- •AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Fertile patients must use effective contraception prior to and during study treatment
- •No known cirrhosis, collagen vascular disease, multiple sclerosis, or HIV positivity
- •No other prior or concurrent malignancies except for non-melanoma skin cancers or carcinoma in situ of the cervix
- •Other prior malignancies allowed provided the patient has been disease-free for > 5 years
- •No uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •No psychiatric or social illness that would limit compliance with study requirements
- •No history of allergy or other adverse response to ginseng products
- •No history of seasonal or environmental allergies that require ongoing treatment with antihistamines, intranasal corticosteroids, or systemic corticosteroids
- •PRIOR CONCURRENT THERAPY:
- •More than 3 months since prior and no concurrent chlorambucil
- •At least 1 month since prior and no other concurrent herbal ginseng products
- •No prior or concurrent fludarabine, alemtuzumab, rituximab, intravenous immunoglobulin, or hematopoietic stem cell transplantation
- •No concurrent corticosteroids (20 mg/day of prednisone or equivalent)
- •No concurrent antibiotic prophylaxis, except for trimethoprim-sulfamethoxazole
- •No concurrent warfarin
- •No other concurrent investigational or commercial agents or other therapies with the intent to treat the patient's malignancy
排除标准
- 未提供
研究组 & 干预措施
Arm II - Placebo
Placebo Comparator
Patients receive oral placebo twice daily.
干预措施: Placebo (Dietary Supplement)
Arm I - Ginseng
Experimental
Patients receive oral American ginseng extract twice daily.
干预措施: American ginseng (Dietary Supplement)
结局指标
主要结局
Acute Respiratory Infection (ARI) Days
时间窗: 3 months
An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.
次要结局
- Number of Antibiotic Use Days(3 months)
研究者
研究点 (125)
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