Kidney CancerNCT00080873
Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
A study testing Traumeel S in people with Kidney Cancer and Leukemia, run by Children's Oncology Group at 44 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 25 years
- Conditions the study is for
- Kidney Cancer, Leukemia, Lymphoma
- What is being tested?
- Traumeel S
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 44 sitesin 4 countries
- Study dates
- Apr 2004to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
44 sites in 4 countries.
44 sites in 4 countries
United States37 sites
C.S. Mott Children's Hospital at University of Michigan
Ann Arbor, Michigan, 48109-0238
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, 02111
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106-5000
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104-9958
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0232
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, 49503-2560
Cancer Research Center of Hawaii
Honolulu, Hawaii, 95813
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1083
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Nemours Children's Clinic
Jacksonville, Florida, 32207
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Children's Hospitals and Clinics of Minneapolis
Minneapolis, Minnesota, 55404
University of Minnesota Medical Center & Children's Hospital - Fairview
Minneapolis, Minnesota, 55455
Schneider Children's Hospital
New Hyde Park, New York, 11040
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507-1971
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229-3993
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110
All Children's Hospital
St. Petersburg, Florida, 33701
Stanford Comprehensive Cancer Center at Stanford University Medical Center
Stanford, California, 94305
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, 33607
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461
New York Medical College
Valhalla, New York, 10595
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Australia3 sites
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Prince of Wales Private Hospital
Randwick, New South Wales, 2031
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, 2145
Canada3 sites
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 3N6
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, H3H 1P3
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
About this study
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
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.
Read the 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.
- Conditions
- Kidney Cancer, Leukemia, Lymphoma, Neuroblastoma, Oral Complications, Sarcoma
- Being tested
- Traumeel S, Placebo
- 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
- Medical subject headings
- Kidney Neoplasms, Leukemia, Lymphoma, Neuroblastoma, Sarcoma, Wilms Tumor, Recurrence, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumeel SDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Receive Traumeel S | Experimental | Not described Receives: Drug: Traumeel S |
| Receive placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Length of study
Secondary outcomes (1)
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.
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study startApr 2004
- Primary completionNov 2006
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan F. Sencer, MD, Study chair, Children's Hospitals and Clinics of Minnesota - MinneapolisIndira Sahdev, MD, Study chair, Schneider Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080873
- Sponsor's protocol ID
- ACCL0331
- Other IDs
- CDR0000356179, COG-ACCL0331
- Status last verified
- Feb 2014
- First submitted
- 7 Apr 2004
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sencer 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.
PubMed 22504933
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00080873
- Acronym / sponsor ID
- ACCL0331
- Conditions
- Kidney Cancer, Leukemia, Lymphoma, Neuroblastoma, Oral Complications, Sarcoma
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive Traumeel S | Experimental | Drug: Traumeel S |
| Receive placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traumeel S | Drug | Receive Traumeel S |
| Placebo | Other | Receive placebo |
Primary outcome
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.
1 secondary outcome
Two sample t test and the Wilcoxon sum test.
Time frame: Length of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- Results publication: PubMed 22504933Sencer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan F. Sencer, MD study chair
Children's Hospitals and Clinics of Minnesota - Minneapolis
Indira Sahdev, MD study chair
Schneider Children's Hospital
44 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traumeel S in people with Kidney Cancer and Leukemia, run by Children's Oncology Group at 44 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Australia, Canada, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of the modified Walsh mucositis scale (time frame: Length of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00080873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.