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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT00752895
First received: September 13, 2008
Last updated: April 3, 2013
Last verified: April 2013

September 13, 2008
April 3, 2013
September 2008
December 2008   (final data collection date for primary outcome measure)
Number of acute respiratory infection (ARI) days during a fixed 3-month period [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of ARI days during a fixed 3-month period [ Designated as safety issue: No ]
  • Safety according to NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00752895 on ClinicalTrials.gov Archive Site
  • Number of antibiotic use days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Rate of all infections [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Duration and severity of each ARI episode [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence of major infections [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence of herpes zoster [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Chronic lymphocytic leukemia disease activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence and type of ARI in untreated cohort [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence of confirmed influenza and respiratory syncytial virus by a physician [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of antibiotic use days [ Designated as safety issue: No ]
  • Rate of all infections [ Designated as safety issue: No ]
  • Duration and severity of each acute respiratory infection (ARI) episode [ Designated as safety issue: No ]
  • Incidence of major infections [ Designated as safety issue: No ]
  • Incidence of herpes zoster [ Designated as safety issue: No ]
  • CLL disease activity [ Designated as safety issue: No ]
  • Incidence and type of ARI in untreated cohort [ Designated as safety issue: No ]
  • Incidence of confirmed influenza and RSV by a physician [ Designated as safety issue: No ]
Not Provided
Not Provided
 
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
A Phase III 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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Leukemia
  • Dietary Supplement: American ginseng
    Given orally
  • Dietary Supplement: placebo
    Given orally
  • Experimental: Arm I
    Patients receive oral American ginseng extract twice daily.
    Intervention: Dietary Supplement: American ginseng
  • Placebo Comparator: Arm II
    Patients receive oral placebo twice daily.
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
293
June 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00752895
CCCWFU98308, U10CA081851
Yes
Wake Forest Cancer Center CCOP Research Base
Wake Forest Cancer Center CCOP Research Base
National Cancer Institute (NCI)
Principal Investigator: Kevin High, MD Comprehensive Cancer Center of Wake Forest University
Wake Forest Cancer Center CCOP Research Base
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP