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

Not Recruiting

Trial ID: NCT00080873

Age - 3-25 Gender - ALL Accepting Healthy Volunteers - No

Purpose

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.

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

Eligibility

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

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Intervention(s):

drug: Traumeel S

other: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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