American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
This study has been completed.
Sponsor:
Wake Forest Cancer Center CCOP Research Base
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT00752895
First received: September 13, 2008
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
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 phase III 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Dietary Supplement: American ginseng Dietary Supplement: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Wake Forest Cancer Center CCOP Research Base:
Primary Outcome Measures:
- Number of acute respiratory infection (ARI) days during a fixed 3-month period [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of antibiotic use days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Rate of all infections [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Duration and severity of each ARI episode [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Incidence of major infections [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Incidence of herpes zoster [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Chronic lymphocytic leukemia disease activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Incidence and type of ARI in untreated cohort [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Incidence of confirmed influenza and respiratory syncytial virus by a physician [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 293 |
| Study Start Date: | September 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral American ginseng extract twice daily.
|
Dietary Supplement: American ginseng
Given orally
|
|
Placebo Comparator: Arm II
Patients receive oral placebo twice daily.
|
Dietary Supplement: placebo
Given orally
|
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 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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 < 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752895
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| United States, California | |
| Providence Saint Joseph Medical Center - Burbank | |
| Burbank, California, United States, 91505 | |
| St. Joseph Hospital Regional Cancer Center - Orange | |
| Orange, California, United States, 92868 | |
| United States, Connecticut | |
| Helen and Harry Gray Cancer Center at Hartford Hospital | |
| Hartford, Connecticut, United States, 06102-5037 | |
| United States, Illinois | |
| Saint Anthony's Hospital at Saint Anthony's Health Center | |
| Alton, Illinois, United States, 62002 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60504 | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Evanston Northwestern Healthcare - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Galesburg Cottage Hospital | |
| Galesburg, Illinois, United States, 61401 | |
| Galesburg Clinic, PC | |
| Galesburg, Illinois, United States, 61401 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| Hopedale Medical Complex | |
| Hopedale, Illinois, United States, 61747 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | |
| Moline, Illinois, United States, 61265 | |
| Good Samaritan Regional Health Center | |
| Mt. Vernon, Illinois, United States, 62864 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| St. Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| St. Vincent Indianapolis Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| St. Vincent Oncology Center | |
| Indianapolis, Indiana, United States, 46260 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| United States, Iowa | |
| Hematology Oncology Associates of the Quad Cities | |
| Bettendorf, Iowa, United States, 52722 | |
| Genesis Medical Center - West Campus | |
| Davenport, Iowa, United States, 52804 | |
| Genesis Regional Cancer Center at Genesis Medical Center | |
| Davenport, Iowa, United States, 52803 | |
| United States, Kansas | |
| Cancer Center of Kansas, PA - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas, PA - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas-Independence | |
| Independence, Kansas, United States, 67301 | |
| Cancer Center of Kansas, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Cancer Center of Kansas, PA - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, PA - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, PA - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center - Baton Rouge | |
| Baton Rouge, Louisiana, United States, 70809 | |
| Pennington Cancer Center at Baton Rouge General | |
| Baton Rouge, Louisiana, United States, 70806 | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| Medical Center of Louisiana - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Michigan | |
| Hickman Cancer Center at Bixby Medical Center | |
| Adrian, Michigan, United States, 49221 | |
| Green Bay Oncology, Limited - Escanaba | |
| Escanaba, Michigan, United States, 49431 | |
| Dickinson County Healthcare System | |
| Iron Mountain, Michigan, United States, 49801 | |
| Haematology-Oncology Associates of Ohio and Michigan, PC | |
| Lambertville, Michigan, United States, 48144 | |
| Community Cancer Center of Monroe | |
| Monroe, Michigan, United States, 48162 | |
| Mercy Memorial Hospital - Monroe | |
| Monroe, Michigan, United States, 48162 | |
| United States, Minnesota | |
| MeritCare Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| United States, Missouri | |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | |
| Cape Girardeau, Missouri, United States, 63701 | |
| Saint Francis Medical Center | |
| Cape Girardeau, Missouri, United States, 63703 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| David C. Pratt Cancer Center at St. John's Mercy | |
| Saint Louis, Missouri, United States, 63141 | |
| Midwest Hematology Oncology Group, Incorporated | |
| Saint Louis, Missouri, United States, 63109 | |
| United States, Montana | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| St. Vincent Healthcare Cancer Care Services | |
| Billings, Montana, United States, 59101 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Billings Clinic - Downtown | |
| Billings, Montana, United States, 59107-7000 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59101 | |
| Bozeman Deaconess Cancer Center | |
| Bozeman, Montana, United States, 59715 | |
| St. James Healthcare Cancer Care | |
| Butte, Montana, United States, 59701 | |
| Great Falls Clinic - Main Facility | |
| Great Falls, Montana, United States, 59405 | |
| Northern Montana Hospital | |
| Havre, Montana, United States, 59501 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Medical Oncology at KRMC | |
| Kalispell, Montana, United States, 59901 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59807 | |
| Guardian Oncology and Center for Wellness | |
| Missoula, Montana, United States, 59804 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59807-7877 | |
| United States, Nebraska | |
| Cancer Resource Center - Lincoln | |
| Lincoln, Nebraska, United States, 68510 | |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | |
| Omaha, Nebraska, United States, 68124 | |
| Creighton University Medical Center | |
| Omaha, Nebraska, United States, 68131-2197 | |
| United States, New Hampshire | |
| Center for Cancer Care at Exeter Hospital | |
| Exeter, New Hampshire, United States, 03833 | |
| United States, New York | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11042 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| MeritCare Broadway | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Hematology Oncology Center | |
| Elyria, Ohio, United States, 44035 | |
| Lima Memorial Hospital | |
| Lima, Ohio, United States, 45804 | |
| St. Luke's Hospital | |
| Maumee, Ohio, United States, 43537 | |
| Northwest Ohio Oncology Center | |
| Maumee, Ohio, United States, 43537 | |
| St. Charles Mercy Hospital | |
| Oregon, Ohio, United States, 43616 | |
| North Coast Cancer Care, Incorporated | |
| Sandusky, Ohio, United States, 44870 | |
| Flower Hospital Cancer Center | |
| Sylvania, Ohio, United States, 43560 | |
| Mercy Hospital of Tiffin | |
| Tiffin, Ohio, United States, 44883 | |
| Toledo Clinic, Incorporated - Main Clinic | |
| Toledo, Ohio, United States, 43623 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43617 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sanford Cancer Center at Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Texas | |
| Presbyterian Hospital of Dallas | |
| Dallas, Texas, United States, 75231 | |
| United States, Virginia | |
| Fredericksburg Oncology, Incorporated | |
| Fredericksburg, Virginia, United States, 22401 | |
| United States, Wisconsin | |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| St. Mary's Hospital Medical Center - Green Bay | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| Bay Area Cancer Care Center at Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| Green Bay Oncology, Limited - Oconto Falls | |
| Oconto Falls, Wisconsin, United States, 54154 | |
| Green Bay Oncology, Limited - Sturgeon Bay | |
| Sturgeon Bay, Wisconsin, United States, 54235 | |
| United States, Wyoming | |
| Welch Cancer Center at Sheridan Memorial Hospital | |
| Sheridan, Wyoming, United States, 82801 | |
Sponsors and Collaborators
Wake Forest Cancer Center CCOP Research Base
Investigators
| Principal Investigator: | Kevin High, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Wake Forest Cancer Center CCOP Research Base |
| ClinicalTrials.gov Identifier: | NCT00752895 History of Changes |
| Other Study ID Numbers: | CCCWFU98308, U10CA081851 |
| Study First Received: | September 13, 2008 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Wake Forest Cancer Center CCOP Research Base:
|
stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Respiratory Tract Infections Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Infection Respiratory Tract Diseases Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013