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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

3 Years
25 Years
Not Enrolling
Kidney Cancer, Leukemia, Lymphoma, Neuroblastoma, Oral Complications, Sarcoma

Thank you

Trial Information

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


- 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

- 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.

Inclusion Criteria


- Planned treatment with allogeneic or autologous hematopoietic stem cell

- 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



- 3 to 25

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- No known allergy to Echinacea

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy

- See Disease Characteristics


- See Disease Characteristics

Endocrine therapy

- Not specified


- Not specified


- Not specified


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Susan F. Sencer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospitals and Clinics of Minnesota - Minneapolis


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Neuroblastoma
  • Oral Complications
  • Sarcoma
  • 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
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Leukemia
  • Lymphoma
  • Neuroblastoma
  • Mucositis
  • Sarcoma



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
New York Medical College Valhalla, New York  10595
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Nemours Children's Clinic Jacksonville, Florida  32207
All Children's Hospital St. Petersburg, Florida  33701
Children's Hospital of New Orleans New Orleans, Louisiana  70118
Schneider Children's Hospital New Hyde Park, New York  11042
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa, Florida  33607
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Floating Hospital for Children at Tufts - New England Medical Center Boston, Massachusetts  02111
C.S. Mott Children's Hospital at University of Michigan Ann Arbor, Michigan  48109-0238
Children's Hospitals and Clinics of Minneapolis Minneapolis, Minnesota  55404
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Rainbow Babies and Children's Hospital Cleveland, Ohio  44106-5000
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Spectrum Health Hospital - Butterworth Campus Grand Rapids, Michigan  49503
University of Minnesota Medical Center & Children's Hospital - Fairview Minneapolis, Minnesota  55455
Stanford Comprehensive Cancer Center at Stanford University Medical Center Stanford, California  94305