Clinical trial · Interventional

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

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

NCT00080873CI-TRIAL-00020450completedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Kidney Cancer	Malignant Kidney Neoplasm	CURATED_EXACT	0.92
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90
Oral Complications	—	UNRESOLVED	—
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Placebo	Other	—	UNRESOLVED
Traumeel S	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Receive Traumeel S
interventionNames
1. Drug: Traumeel S
type
PLACEBO_COMPARATOR
label
Receive placebo
interventionNames
1. Other: Placebo

Primary outcomes (1)

measure
Area under the curve (AUC) of the modified Walsh mucositis scale
timeFrame
Length of study
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 3 Years
Maximum age: 25 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTSencer SF, Zhou T, Freedman LS, Ives JA, Chen Z, Wall D, Nieder ML, Grupp SA, Yu LC, Sahdev I, Jonas WB, Wallace JD, Oberbaum M. Traumeel S in preventing and treating mucositis in young patients undergoing SCT: a report of the Children's Oncology Group. Bone Marrow Transplant. 2012 Nov;47(11):1409-14. doi: 10.1038/bmt.2012.30. Epub 2012 Apr 16. PMID 22504933

Registry

Dates and enrollment

Start: Apr 1, 2004
Primary completion: Nov 1, 2006
Completion: Jan 1, 2011
First posted: Apr 8, 2004
Last update posted: Jan 7, 2016
Enrollment: 195 (actual)
Lead sponsor: Children's Oncology Group NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: 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

Data updated 22 days agoSource updated Jan 7, 2016source: clinicaltrials

Locations

Country	Sites	Recruiting
United States	37	0
Australia	3	0
Canada	3	0
Israel	1	0