American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With Chronic Lymphocytic Leukemia

Official Title: “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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: American ginseng
  • Given orally
• Other: placebo
  • Given orally

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm I
  • Patients receive oral American ginseng extract twice daily.
• Placebo Comparator: Arm II
  • Patients receive oral placebo twice daily.

Primary Measures

• Number of acute respiratory infection (ARI) days during a fixed 3-month period
  • Safety Issue?: No
• Safety according to NCI CTCAE v3.0
  • Safety Issue?: Yes

Secondary Measures

• Number of antibiotic use days
  • Safety Issue?: No
• Rate of all infections
  • Safety Issue?: No
• Duration and severity of each ARI episode
  • Safety Issue?: No
• Incidence of major infections
  • Safety Issue?: No
• Incidence of herpes zoster
  • Safety Issue?: No
• Chronic lymphocytic leukemia disease activity
  • Safety Issue?: No
• Incidence and type of ARI in untreated cohort
  • Safety Issue?: No
• Incidence of confirmed influenza and respiratory syncytial virus by a physician
  • Safety Issue?: 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
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Wake Forest University Other

Overall Clinical Trial Officials and Contacts

Kevin High, MD Study Chair Comprehensive Cancer Center of Wake Forest University  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00752895

Study ID Number: CDR0000614076

ClinicalTrials.gov Identifier: NCT00752895

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database

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