NCT00080873

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

A Randomized Double Blind Placebo Controlled Clinical Trial to Assess the Efficacy of Traumeel® S (IND#66649) for the Prevention and Treatment of Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 3 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * Compare the efficacy of Traumeel® S vs placebo in reducing the severity and duration of chemotherapy-induced (with or without total body irradiation) mucositis in pediatric patients undergoing hematopoietic stem cell transplantation. * Determine the safety of this drug in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to treatment with total body irradiation during conditioning chemotherapy (yes vs no), type of transplantation (autologous vs allogeneic), and participating institution (COG vs foreign). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral Traumeel® S mouth rinse 5 times daily beginning on day -1 before transplantation. * Arm II: Patients receive oral placebo mouth rinse 5 times daily beginning on day -1 before transplantation. In both arms, treatment continues until day 20 post-transplantation OR until mucositis resolves to Walsh score ≤ 1 for 2 consecutive days. Patients are followed until day 100 post-transplantation. PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study within 2 years.

Conditions

• Kidney Cancer
• Leukemia
• Lymphoma
• Neuroblastoma
• Oral Complications
• Sarcoma

Interventions

Type	Name	Description
DRUG	Traumeel S
OTHER	Placebo

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-11-01
• Completion: 2011-01-01
• First posted: 2004-04-08
• Last updated: 2016-01-07

Locations

44 sites across 4 countries: United States, Australia, Canada, Israel