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

Leukemia Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Respiratory Tract Infections

• NCT number: NCT00752895
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2008
• Completion date: June 1, 2009