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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00080873




Registration number
NCT00080873
Ethics application status
Date submitted
7/04/2004
Date registered
8/04/2004
Date last updated
7/01/2016

Titles & IDs
Public title
Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
Scientific 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
Secondary ID [1] 0 0
CDR0000356179
Secondary ID [2] 0 0
ACCL0331
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Cancer 0 0
Leukemia 0 0
Lymphoma 0 0
Neuroblastoma 0 0
Oral Complications 0 0
Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Traumeel S
Other interventions - Placebo

Experimental: Receive Traumeel S -

Placebo Comparator: Receive placebo -


Treatment: Drugs: Traumeel S


Other interventions: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the curve (AUC) of the modified Walsh mucositis scale - 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.
Timepoint [1] 0 0
Length of study
Secondary outcome [1] 0 0
Two sample t test and the Wilcoxon sum test. - 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.
Timepoint [1] 0 0
Length of study

Eligibility
Key inclusion 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
Minimum age
3 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [2] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
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Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Israel
State/province [26] 0 0
Tel Hashomer

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00080873
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susan F. Sencer, MD
Address 0 0
Children's Hospitals and Clinics of Minnesota - Minneapolis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications