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NCT Number: NCT00080873

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

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.

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Key information

Conditions

Kidney Cancer Bone Marrow Diseases Burkitt Lymphoma Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Epstein-Barr Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Infections Kidney Diseases Kidney Neoplasms Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myelomonocytic, Juvenile Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Syndromes, Hereditary Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Oral Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence Sarcoma Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Virus Diseases Wilms Tumor

Age range

3 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Private Hospital, Randwick, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traumeel S

Drug

Placebo

Other

Primary outcomes

  1. Area under the curve (AUC) of the modified Walsh mucositis scale

    Time frame: Length of study

    The primary aim of drug efficacy will be measured by the area under the curve (AUC) of the modified Walsh mucositis scale. Scores will be assigned for each region of oral mucosa and totaled for daily score. AUC will be obtained by graphing the total scores recorded every day during follow-up, linking time adjacent points by a straight line and calculating the area under the resulting polygon. The measurement of AUC incorporates both severity and duration of symptoms.

Secondary outcomes

  1. Two sample t test and the Wilcoxon sum test.

    Time frame: Length of study

    Total amount of narcotics used, days of total TPN and NG feedings in patients who receive Traumeel® S and placebo will be compared. The statistical tests to be applied are the two sample t test and the Wilcoxon sum test.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2011
First posted
Apr 8, 2004
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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