Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Coping with Cancer 2 Managing side effects and complications caused by cancer and its treatment. Childhood Cancers Home Page 3 NCI's gateway for information about pediatric cancers.

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 ⁴.

Principal Investigators

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

Dr. Susan Sencer Principal Investigator

Why This Trial Is 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."

Contact Information

This trial is no longer enrolling new patients. To find other supportive care clinical trials, search the NCI database of clinical trials ¹ or call the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and confidential.

Glossary Terms

Forms of treatment that are used in addition to (complementary) or instead of (alternative) standard treatments. These practices generally are not considered standard medical approaches. Standard treatments go through a long and careful research process to prove they are safe and effective, but less is known about most types of CAM. CAM may include dietary supplements, megadose vitamins, herbal preparations, special teas, acupuncture, massage therapy, magnet therapy, spiritual healing, and meditation. Also called CAM.

An alternative approach to medicine based on the belief that natural substances, prepared in a special way and used most often in very small amounts, restore health. According to these beliefs, in order for a remedy to be effective, it must cause in a healthy person the same symptoms being treated in the patient. Also called homeopathy.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

A method of replacing immature blood-forming cells that were destroyed by cancer treatment. The stem cells are given to the person after treatment to help the bone marrow recover and continue producing healthy blood cells.