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Phase III Randomized Study of American Ginseng Extract to Prevent Respiratory Infection and Reduce Antibiotic Use in Patients With Chronic Lymphocytic Leukemia
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With Chronic Lymphocytic Leukemia
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III | Supportive care | Closed | 18 and over | CCCWFU-98308 CCCWFU # 98308, NCT00752895 |
Special Category:
NCI Web site featured trial 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 patients with chronic lymphocytic leukemia (CLL).
- To determine the safety of American ginseng extract in these patients evaluated according to NCI CTCAE v3.0.
Secondary - To assess the effect of this treatment on antibiotic use days (AUDs).
- To assess the effect of this treatment on the rate of all infections diagnosed by a physician.
- To assess the effect of this treatment on the duration and severity of each ARI episode.
- To assess the effect of this treatment on major infections defined as infection severe enough to require hospitalization or intravenous antibiotics.
- To assess the effect of this treatment on the incidence of herpes zoster infection defined as an episode of physician-diagnosed zoster infection.
- To assess the effect of this treatment on CLL disease activity (i.e., serum IgG, total lymphocyte count, platelet count, and Rai staging).
- To determine the incidence of ARI and type of illness in an untreated cohort of CLL patients over an entire winter respiratory illness season (January 1- April 30).
Tertiary - To determine the effect of this treatment on the incidence of influenza and respiratory syncytial virus confirmed by a physician.
Entry Criteria Disease Characteristics:
- Diagnosis of chronic lymphocytic leukemia (CLL)
- Phenotypic evidence (i.e., flow cytometry or bone marrow biopsy) of disease
- Untreated CLL allowed
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
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
Expected Enrollment 336Outcomes Primary Outcome(s)Number of acute respiratory infection (ARI) days during a fixed 3-month period Safety according to NCI CTCAE v3.0
Secondary Outcome(s)Number of antibiotic use days Rate of all infections Duration and severity of each ARI episode Incidence of major infections Incidence of herpes zoster Chronic lymphocytic leukemia disease activity Incidence and type of ARI in untreated cohort Incidence of confirmed influenza and respiratory syncytial virus by a physician
Outline This is a multicenter study. Patients are stratified according to antibiotic prophylaxis with trimethoprim-sulfamethoxazole (yes vs no), serum IgG (≤ 500 mg/dL vs > 500 mg/dL), and influenza vaccine status (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral American ginseng extract twice daily.
- Arm II: Patients receive oral placebo twice daily.
Treatment in both arms continues for up to 4 months in the absence of illness or adverse events. After completion of study treatment, patients are followed at 4 weeks by phone.
Trial Contact Information
Trial Lead Organizations Wake Forest University CCOP Research Base | | | Kevin High, MD, Protocol chair | | Ph: 336-716-4584; 800-446-2255 |
| | Bayard Powell, MD, Protocol co-chair | | | | David Hurd, MD, Protocol co-chair | | | | Denise Levitan, MD, Protocol co-chair | | | | Leslie Ellis, MD, Protocol co-chair | | Ph: 336-716-5847; 800-446-2255 |
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Related Information Featured trial article
Registry Information | | Official Title | | A Phase III 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 | | Trial Start Date | | 2008-09-11 | | Trial Completion Date | | 2009-04-30 (estimated) | | Registered in ClinicalTrials.gov | | NCT00752895 | | Date Submitted to PDQ | | 2008-09-09 | | Information Last Verified | | 2009-01-01 | | NCI Grant/Contract Number | | CA12197 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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