Status:
COMPLETED
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 effectiv...
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 patien...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00752895
Start Date
September 1 2008
End Date
June 1 2009
Last Update
September 28 2021
Active Locations (125)
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1
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
2
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868
3
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
4
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002