ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00080873
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : January 7, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief 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.


Condition or disease Intervention/treatment Phase
Kidney Cancer Leukemia Lymphoma Neuroblastoma Oral Complications Sarcoma Drug: Traumeel S Other: Placebo Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Supportive Care
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
Study Start Date : April 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : January 2011


Arm Intervention/treatment
Experimental: Receive Traumeel S Drug: Traumeel S
Placebo Comparator: Receive placebo Other: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080873


  Show 44 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Susan F. Sencer, MD Children's Hospitals and Clinics of Minnesota - Minneapolis
Study Chair: Indira Sahdev, MD Schneider Children's Hospital

Publications of Results:
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00080873     History of Changes
Obsolete Identifiers: NCT00228800
Other Study ID Numbers: ACCL0331
CDR0000356179 ( Other Identifier: Clinical Trials.gov )
COG-ACCL0331 ( Other Identifier: Children's Oncology Group )
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: February 2014

Keywords provided by Children's Oncology Group:
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

Additional relevant MeSH terms:
Lymphoma
Leukemia
Neuroblastoma
Kidney Neoplasms
Carcinoma, Renal Cell
Mucositis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases