Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT00080873|
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : January 7, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer Leukemia Lymphoma Neuroblastoma Oral Complications Sarcoma||Drug: Traumeel S Other: Placebo||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||195 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||January 2011|
|Experimental: Receive Traumeel S||
Drug: Traumeel S
|Placebo Comparator: Receive placebo||
- Area under the curve (AUC) of the modified Walsh mucositis scale [ Time Frame: Length of study ]The primary aim of drug efficacy will be measured by the area under the curve (AUC) of the modified Walsh mucositis scale. Scores will be assigned for each region of oral mucosa and totaled for daily score. AUC will be obtained by graphing the total scores recorded every day during follow-up, linking time adjacent points by a straight line and calculating the area under the resulting polygon. The measurement of AUC incorporates both severity and duration of symptoms.
- Two sample t test and the Wilcoxon sum test. [ Time Frame: Length of study ]Total amount of narcotics used, days of total TPN and NG feedings in patients who receive Traumeel® S and placebo will be compared. The statistical tests to be applied are the two sample t test and the Wilcoxon sum test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080873
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|Study Chair:||Susan F. Sencer, MD||Children's Hospitals and Clinics of Minnesota - Minneapolis|
|Study Chair:||Indira Sahdev, MD||Schneider Children's Hospital|