CompletedNot Applicable

Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation

United States195 participantsStarted 2004-04

Plain-language summary

RATIONALE: Traumeel® S (a mouth rinse) may be effective in preventing or decreasing the severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem cell transplantation. PURPOSE: This randomized clinical trial is studying how well Traumeel® S works in preventing or treating mucositis in young patients who are receiving chemotherapy with or without total-body irradiation before undergoing stem cell transplantation.

Who can participate

Age range3 Years – 25 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Planned treatment with allogeneic or autologous hematopoietic stem cell transplantation * Conditioning chemotherapy regimen for transplantation must be myeloablative * Source of stem cells from any of the following: * Bone marrow * Placental cord * Cytokine-mobilized peripheral blood * Availability of 1 of the following donor types: * HLA-matched sibling or parent * Related donor mismatched for a single HLA locus (class I or II) * Unrelated marrow or peripheral blood stem cell donor * Unrelated umbilical cord blood HLA-matched or mismatched (class I) donor PATIENT CHARACTERISTICS: Age * 3 to 25 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No known allergy to Echinacea * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No concurrent oral vancomycin paste * No concurrent oral glutamine supplementation * No other mouth care or oral medications within 30 minutes after administration of study drugs * No other concurrent treatment to prevent mouth sores

What they're measuring

Area under the curve (AUC) of the modified Walsh mucositis scale

Timeframe: Length of study

Trial details

NCT IDNCT00080873

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2006-11