Phase 2
Completed N=293
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
Source: ClinicalTrials.gov NCT00752895 ↗Enrolled (actual)
293
Serious AEs
9.5%
Results posted
Nov 2015
Primary outcomePrimary: Acute Respiratory Infection (ARI) Days — 8.30; 6.78 days — p=0.295
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Respiratory Infection (ARI) Days |
8.30; 6.78 | 0.295 |
| SECONDARY Number of Antibiotic Use Days |
1.12; 1.55 | 0.820 |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00752895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.