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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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00752895
First received: September 13, 2008
Last updated: June 21, 2017
Last verified: June 2017
September 13, 2008
June 21, 2017
September 2008
December 2008   (Final data collection date for primary outcome measure)
Acute Respiratory Infection (ARI) Days [ Time Frame: 3 months ]
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.
  • Number of ARI days during a fixed 3-month period
  • Safety according to NCI CTCAE v3.0
Complete list of historical versions of study NCT00752895 on ClinicalTrials.gov Archive Site
Number of Antibiotic Use Days [ Time Frame: 3 months ]
An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.
  • Number of Antibiotic Use Days
  • Rate of all infections
  • Duration and severity of each acute respiratory infection (ARI) episode
  • Incidence of major infections
  • Incidence of herpes zoster
  • CLL disease activity
  • Incidence and type of ARI in untreated cohort
  • Incidence of confirmed influenza and RSV by a physician
Not Provided
Not Provided
 
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Leukemia
  • Dietary Supplement: American ginseng
    Given orally
  • Dietary Supplement: Placebo
    Given orally
  • Experimental: Arm I - Ginseng
    Patients receive oral American ginseng extract twice daily.
    Intervention: Dietary Supplement: American ginseng
  • Placebo Comparator: Arm II - Placebo
    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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00752895
REBACCCWFU98308
U10CA081851 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Wake Forest University Health Sciences
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Principal Investigator: Kevin High, MD Wake Forest University Health Sciences
Wake Forest University Health Sciences
June 2017

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