NCT00752895
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
PHASE2
COMPLETED
NCT00752895
INTERVENTIONAL
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.
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
Leukemia
- PREVENTION
-
- 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
- Wake Forest University Health Sciences