Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Completed	3 to 25	NCI	COG-ACCL0331 NCT00080873, ACCL0331

Objectives

1. 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.
2. Determine the safety of this drug in these patients.

Entry 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

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

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

Expected Enrollment

A total of 180 patients (90 per treatment arm) will be accrued for this study within 2 years.

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Susan Sencer, MD, Protocol chair		Ph: 612-813-6000 Email: susan.sencer@childrenshc.org
Indira Sahdev, MD, Protocol co-chair		Ph: 718-470-3611 Email: isahdev@lij.edu

Related Information

Featured trial article

Registry Information
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
Trial Start Date		2004-04-26
Trial Completion Date		2006-11-17
Registered in ClinicalTrials.gov		NCT00080873
Date Submitted to PDQ		2004-02-11
Information Last Verified		2009-08-24

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