american ginseng extract in preventing respiratory infection and in reducing antibiotic use in patients with cll

Conditions: Leukemia

Summary: 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.

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.

Eligibility criteria:
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 \ 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

Keywords: stage i chronic lymphocytic leukemia stage ii chronic lymphocytic leukemia stage iii chronic lymphocytic leukemia stage iv chronic lymphocytic leukemia