NCT00752895

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

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Leukemia

Primary Purpose
  • PREVENTION
Intervention/Treatment
    • Type: DIETARY_SUPPLEMENT
    • Name: American ginseng
    • Description: Given orally
    • Arm Group Labels: Arm I - Ginseng
    • Type: DIETARY_SUPPLEMENT
    • Name: Placebo
    • Description: Given orally
    • Arm Group Labels: Arm II - Placebo
Sponsor
  • Wake Forest University Health Sciences