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

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Wake Forest University Health Sciences

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Leukemia	Dietary Supplement: American ginseng Dietary Supplement: Placebo	Phase 2

Detailed 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.

Study Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Leukemia

Drug Information available for: Ginseng American ginseng extract

Genetic and Rare Diseases Information Center resources: Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Show 125 Study Locations

Sponsors and Collaborators

Wake Forest University Health Sciences

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Kevin High, MD	Wake Forest University Health Sciences

More Information


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

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