American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
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ClinicalTrials.gov Identifier: NCT00752895 |
Recruitment Status :
Completed
First Posted : September 16, 2008
Results First Posted : November 2, 2015
Last Update Posted : September 11, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia | Dietary Supplement: American ginseng Dietary Supplement: Placebo | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 293 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I - Ginseng
Patients receive oral American ginseng extract twice daily.
|
Dietary Supplement: American ginseng
Given orally |
Placebo Comparator: Arm II - Placebo
Patients receive oral placebo twice daily.
|
Dietary Supplement: Placebo
Given orally |
- 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 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752895

Principal Investigator: | Kevin High, MD | Wake Forest University Health Sciences |
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT00752895 History of Changes |
Other Study ID Numbers: |
IRB00006819 U10CA081851 ( U.S. NIH Grant/Contract ) REBACCCWFU98308 ( Other Identifier: NCI ) |
First Posted: | September 16, 2008 Key Record Dates |
Results First Posted: | November 2, 2015 |
Last Update Posted: | September 11, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Wake Forest University Health Sciences:
stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
Additional relevant MeSH terms:
Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Respiratory Tract Infections Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Infection Respiratory Tract Diseases Anti-Bacterial Agents Anti-Infective Agents |