COLD-FX remedy undergoes NCI-sponsored trial in leukemia patients

Nov 17 2008

Cancer patients - with their weakened immune systems - are particularly vulnerable when the cold and flu season hits.

To help, the U.S. National Cancer Institute (NCI) is sponsoring a landmark trial to see whether a unique Canadian cold remedy - COLD-FX - can help.

The trial will examine whether using the #1 pharmacist recommended cold and flu fighting product in Canada - ginseng extract COLD-FX - reduces infections in chronic lymphocytic leukemia patients; enabling them to remain healthier to fight their disease. Cancer patients have weakened immune systems to begin with, usually as a result of chemotherapy or radiation.

The trial will be conducted by American cancer and infectious diseases experts at Wake Forest University School of Medicine in North Carolina. Wake Forest currently oversees approximately 150 cancer trials and is regarded as one of America's leading cancer research facilities.

The double-blind, placebo-controlled trial, involving 336 patients, was originally planned to include up to 19 U. S research sites. However, in approving the study, the NCI accelerated the process - targeting completion over a single cold and flu season. To assist in recruitment, it also opened up its cancer trials support unit network of more than 1,500 cancer research sites across the U.S.

The NCI says on its website that the trial is important because both the cancer and its treatment, "…can impair immune system functioning and markedly increase risk of infection, the most common complication…" of chronic lymphocytic leukemia. "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 [acute respiratory infection] in older adults," the website says.

In the battle against respiratory infections, there are few effective and economical treatment options. Apart from COLD-FX, there is no known clinical proven therapy for both prevention and treatment that naturally enhances the immune system to fight viral respiratory infections.

A recently reported three-year, multi-center study of COLD-FX, involving 780 participants, demonstrated that it cut infections by one-third in seniors taking the flu shot. The trial also showed that using a combo of COLD-FX and a flu shot provided greater protection than using the flu shot alone. This research complemented earlier clinical trials that formed the basis of Canada's regulatory approval of 400 milligrams of COLD-FX daily to reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system.