American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL

Study Overview
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Brief Summary
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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.

Detailed Description
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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). Tertiary To determine the effect of this treatment on the incidence of influenza and respiratory syncytial virus confirmed by a physician. OUTLINE: This is a multicenter study. Patients are stratified according to antibiotic prophylaxis with trimethoprim-sulfamethoxazole (yes vs no), serum IgG (≤ 500 mg/dL vs > 500 mg/dL), and influenza vaccine status (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral American ginseng extract twice daily. Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for up to 4 months in the absence of illness or adverse events. After completion of study treatment, patients are followed at 4 weeks by phone.

Official Title
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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

Conditions
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Leukemia

Intervention / Treatment
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* Dietary Supplement: American ginseng
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I - Ginseng<br>Patients receive oral American ginseng extract twice daily. | Dietary Supplement: American ginseng<br>* Given orally<br>|
| Placebo Comparator: Arm II - Placebo<br>Patients receive oral placebo twice daily. | Dietary Supplement: Placebo<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Respiratory Infection (ARI) Days | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Antibiotic Use Days | An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia