American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
- Conditions
- Leukemia
- Interventions
- Dietary Supplement: American ginsengDietary Supplement: Placebo
- Registration Number
- NCT00752895
- Lead Sponsor
- Wake Forest University Health Sciences
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 293
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I - Ginseng American ginseng Patients receive oral American ginseng extract twice daily. Arm II - Placebo Placebo Patients receive oral placebo twice daily.
- Primary Outcome Measures
Name Time Method Acute Respiratory Infection (ARI) Days 3 months An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.
- Secondary Outcome Measures
Name Time Method Number of Antibiotic Use Days 3 months An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.
Trial Locations
- Locations (125)
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Fredericksburg Oncology, Incorporated
🇺🇸Fredericksburg, Virginia, United States
St. Vincent Oncology Center
🇺🇸Indianapolis, Indiana, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
St. Joseph Hospital Regional Cancer Center - Orange
🇺🇸Orange, California, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Evanston Northwestern Healthcare - Evanston Hospital
🇺🇸Evanston, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Genesis Medical Center - West Campus
🇺🇸Davenport, Iowa, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
Dickinson County Healthcare System
🇺🇸Iron Mountain, Michigan, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
MeritCare Bemidji
🇺🇸Bemidji, Minnesota, United States
Center for Cancer Care at Exeter Hospital
🇺🇸Exeter, New Hampshire, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
🇺🇸Cape Girardeau, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Pennington Cancer Center at Baton Rouge General
🇺🇸Baton Rouge, Louisiana, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
Midwest Hematology Oncology Group, Incorporated
🇺🇸Saint Louis, Missouri, United States
Mary Bird Perkins Cancer Center - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Hematology Oncology Center
🇺🇸Elyria, Ohio, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Presbyterian Hospital of Dallas
🇺🇸Dallas, Texas, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
MeritCare Broadway
🇺🇸Fargo, North Dakota, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
🇺🇸Moline, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
🇺🇸Manhasset, New York, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans
🇺🇸New Orleans, Louisiana, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States