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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careCompleted18 and overNCICCCWFU98308
U10CA081851, WFU-07-02-03, NCT00752895

Trial Description


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 phase III 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.

Further Study Information



  • 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.


  • 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).


  • 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


  • Diagnosis of chronic lymphocytic leukemia (CLL)
  • Phenotypic evidence (i.e., flow cytometry or bone marrow biopsy) of disease
  • Untreated CLL allowed


  • 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


  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Wake Forest NCORP Research Base

  • National Cancer Institute
Kevin High, Principal Investigator

Link to the current record.
NLM Identifier NCT00752895 processed this data on April 09, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to