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Columbia University's integrative therapies program for children with cancer, located at Children's Hospital of NewYork-Presbyterian, and the Children's Hospital of Philadelphia are conducting a study to determine if combining chemotherapy drugs with milk thistle could successfully treat liver toxicity, a toxic chemotherapy side effect in children with acute lymphoblastic leukemia (ALL). Successful use of this herb would enable oncologists to continue with more aggressive, sustained chemotherapy regimens to treat ALL, which is the most common childhood cancer, accounting for one out of every three children with cancer. This trial marks the first time that milk thistle, an herb that has been widely tested in Europe for the treatment of liver disease (and studied extensively in clinical trials with adult liver disease patients), will be used in individuals with cancer.

We became interested in milk thistle when so many of our leukemia patients told us they were already taking it, said Dr. Kara Kelly, assistant professor of pediatrics and medical director of the integrative therapies program. While the chemotherapy agents are extremely effective for the treatment of children with leukemia, they are often associated with toxic effects on the liver. Currently, there are no medications that can be used to counteract the effects on the liver. We're hoping that milk thistle can reduce the liver toxicity but more importantly have no adverse effects on the treatment of leukemia.

Surveys have found that up to 85 percent of children with cancer are using some form of alternative medicine, said Elena Ladas, director of the integrative therapies program. Yet its interaction with conventional chemotherapy is unknown. We're hoping that this study may begin to shed some light on the safety of this herb.

The prognosis for ALL patients has improved in recent decades, escalating from 5 percent in the 1960s to nearly 80 percent by the year 2000. Yet, as effective as therapies for ALL are, they can produce considerable side effects: Approximately 25 percent of patients who are given standard ALL chemotherapy drugs during the maintenance phase of treatment will experience liver problems.

Currently, no other chemotherapy drugs are less toxic to the liver and as effective in treating ALL, so patients with this complication are often forced to decrease or delay their chemotherapy doses-potentially increasing their risk of a relapse.

During the course of the study, eligible participants will be assigned to one of two groups, receiving either the active herb or placebo for one month. Patients will be assessed throughout for liver function and monitored routinely for adverse effects. The integrative therapies program is looking to recruit 50 ALL patients between the ages of 2 and 21 who are experiencing liver toxicity due to chemotherapy. For more information on the study, please call 212-305-7835 or email [email protected].