Clinical trial NCT00080873: Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Cancer
Leukemia
Lymphoma
Neuroblastoma
Oral Complications
Sarcoma
Keywords: oral complications
disseminated neuroblastoma
previously treated childhood rhabdomyosarcoma
recurrent Wilms tumor and other childhood kidney tumors
recurrent/refractory childhood Hodgkin lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
recurrent childhood large cell lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood rhabdomyosarcoma
recurrent childhood small noncleaved cell lymphoma
untreated childhood acute lymphoblastic leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
juvenile myelomonocytic leukemia
recurrent neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-08
Enrollment: 195
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve (AUC) of the modified Walsh mucositis scale
timeFrame: Length of study
Secondary outcomes:
measure: Two sample t test and the Wilcoxon sum test.
timeFrame: Length of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Stanford
country: United States
facility: Stanford Comprehensive Cancer Center at Stanford University Medical Center
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
city: St. Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Cancer Institute at St. Joseph's Hospital
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Honolulu
country: United States
facility: Cancer Research Center of Hawaii
state: Hawaii
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Floating Hospital for Children at Tufts - New England Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital at University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospital - Butterworth Campus
state: Michigan
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minneapolis
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center & Children's Hospital - Fairview
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: St. Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital
state: Missouri
city: Bronx
country: United States
facility: Albert Einstein Cancer Center at Albert Einstein College of Medicine
state: New York
city: New Hyde Park
country: United States
facility: Schneider Children's Hospital
state: New York
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center at Columbia University
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Hospital
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Medical Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center - Fort Worth
state: Texas
city: San Antonio
country: United States
facility: Methodist Children's Hospital of South Texas
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of The King's Daughters
state: Virginia
city: Randwick
country: Australia
facility: Prince of Wales Private Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Institute for Cancer Research at Westmead Hospital
state: New South Wales
city: Perth
country: Australia
facility: Princess Margaret Hospital for Children
state: Western Australia
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Children's Hospital at McGill University Health Center
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sainte Justine
state: Quebec
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota - Minneapolis
name: Susan F. Sencer, MD
role: STUDY_CHAIR
affiliation: Schneider Children's Hospital
name: Indira Sahdev, MD
role: STUDY_CHAIR
References:
citation: Sencer SF, Zhou T, Freedman LS, Ives JA, Chen Z, Wall D, Nieder ML, Grupp SA, Yu LC, Sahdev I, Jonas WB, Wallace JD, Oberbaum M. Traumeel S in preventing and treating mucositis in young patients undergoing SCT: a report of the Children's Oncology Group. Bone Marrow Transplant. 2012 Nov;47(11):1409-14. doi: 10.1038/bmt.2012.30. Epub 2012 Apr 16.