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
Both
Kidney Cancer, Leukemia, Lymphoma, Neuroblastoma, Oral Complications, Sarcoma
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
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.
Inclusion 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
Type of Study:
Interventional
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
Authority:
United States: Federal Government
Study ID:
CDR0000356179
NCT ID:
NCT00080873
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
Name | Location |
|---|---|
| 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 |
