Clinical trial · Interventional
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| American ginseng | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I - Ginseng
- description
- Patients receive oral American ginseng extract twice daily.
- interventionNames
- Dietary Supplement: American ginseng
- type
- PLACEBO_COMPARATOR
- label
- Arm II - Placebo
- description
- Patients receive oral placebo twice daily.
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
- Acute Respiratory Infection (ARI) Days
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available