Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

Susan F. Sencer

Study Chair

Indira Sahdev

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00080873
Information obtained from ClinicalTrials.gov on November 20, 2012

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