Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
- Conditions
- LymphomaKidney CancerLeukemiaNeuroblastomaSarcomaOral Complications
- Interventions
- Drug: Traumeel SOther: Placebo
- Registration Number
- NCT00080873
- Lead Sponsor
- Children's Oncology Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Receive Traumeel S Traumeel S - Receive placebo Placebo -
- Primary Outcome Measures
Name Time Method Area under the curve (AUC) of the modified Walsh mucositis scale 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.
- Secondary Outcome Measures
Name Time Method Two sample t test and the Wilcoxon sum test. 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.
Related Research Topics
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Trial Locations
- Locations (44)
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Cancer Centre of Southeastern Ontario at Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
C.S. Mott Children's Hospital at University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
🇺🇸Minneapolis, Minnesota, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Floating Hospital for Children at Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Stanford Comprehensive Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Children's Hospitals and Clinics of Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Prince of Wales Private Hospital
🇦🇺Randwick, New South Wales, Australia
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States