Name of the Trial
Randomized Study of Traumeel S for the Prevention and Treatment of Mucositis in Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation (COG-ACCL0331). See the protocol summary at http://cancer.gov/clinicaltrials/COG-ACCL0331.

Principal Investigators
Dr. Susan Sencer and Dr. Indira Sahdev of the Children's Oncology Group.

Why Is This Trial Important?
Chemotherapy drugs for cancer may produce a number of side effects. These side effects can prevent or delay further treatment and may lead to serious complications, including infection and death. Therefore, researchers are eager to find effective ways to prevent or lessen side effects from chemotherapy.

Mucositis (sores and ulcers in the lining of the mouth) is a common side effect of chemotherapy. This trial is testing a homeopathic preparation, called Traumeel S, as a treatment for mucositis in young patients undergoing chemotherapy in preparation for stem cell transplantation. High-dose chemotherapy and stem cell transplantation are frequently used in treating pediatric patients with leukemia or solid tumors. Traumeel S is a homeopathic remedy containing certain minerals and extracts from 12 different types of plants.

"An earlier study of Traumeel S conducted in Israel showed a significant reduction in mucositis among young patients undergoing stem cell transplantation," said Dr. Sencer. "With this trial, we hope to confirm those findings and therefore determine whether Traumeel S is an effective treatment for chemotherapy-related mucositis.

"There is a great deal of interest in complementary and alternative medicines among the public and studies have shown that our patients are using them," added Dr. Sencer. "We feel we have a responsibility to test these methods as rigorously as we would test any other intervention."

Who Can Join This Trial?
Researchers seek to enroll 180 patients aged 3 to 25 who are undergoing myeloablative stem cell transplants. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/COG-ACCL0331.

Where Is This Trial Taking Place?
The study is part of the NCI's Community Clinical Oncology Program and is being conducted at sites in the United States and elsewhere. See the list of study sites at http://cancer.gov/clinicaltrials/COG-ACCL0331.

Contact Information
For more information, see the list of study contacts at http://cancer.gov/clinicaltrials/COG-ACCL0331 or call the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and confidential.