Name of the Trial
Phase III Randomized Study of American Ginseng Extract to Prevent Respiratory Infection and Reduce Antibiotic Use in Patients with Chronic Lymphocytic Leukemia (CCCWFU-98308). See the protocol summary at http://www.cancer.gov/clinicaltrials/CCCWFU-98308.

Principal Investigators
Drs. Kevin High, Bayard Powell, David Hurd, Denise Levitan, and Leslie Ellis, Wake Forest University CCOP Research Base

Why This Trial Is Important
Chronic lymphocytic leukemia (CLL) is a type of blood cancer that progresses very slowly over many years. Most patients are started on treatment only when needed. Both CLL and its treatment can impair immune system functioning and markedly increase risk of infection, the most common complication of CLL.

The advanced age of most people with CLL (70 percent over age 65) is also a risk factor for infection. Acute respiratory infection (ARI) is the most common infection in CLL patients. Although there are no published data on the occurrence of ARI in untreated CLL patients, these individuals appear to be more prone to infection than people of similar age with non-cancerous conditions. Recent studies suggest the average number of days with ARI during the winter season is about 8 among cancer-free individuals who are roughly the same age as CLL patients.

Two randomized, controlled trials have shown that an extract of North American Ginseng, called CVT-E002 (COLD-fX), can significantly reduce the risk of ARI in older adults. Other research suggests that the active ingredient in CVT-E002 enhances the function of certain white blood cells (macrophages and natural killer cells) that are part of the immune system.

These results led to the development of this randomized, double-blind, placebo-controlled study to test the ability of CVT-E002 to reduce ARI and the need for antibiotic treatment during the peak respiratory illness season (January through March) in people with CLL. All patients will be enrolled between November 1 and December 31, 2008. Once patients are identified and informed consent obtained, they will be randomly assigned to receive either CVT-E002 (200 mg orally twice a day) or matching placebo pills. Treatment will continue through April 30, 2009. The researchers want to see if CVT-E002 can reduce the number of days with ARI by 30 percent, as well as antibiotic use among CLL patients over a 3-month period (January 1-March 31).

For More Information
See the lists of entry criteria and trial contact information at http://www.cancer.gov/clinicaltrials/CCCWFU-98308 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.