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

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00080873

Collaborator

National Cancer Institute (NCI) (NIH)

195

Enrollment

Locations

Arms

Duration (Months)

4.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Apr 1, 2004

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Receive Traumeel S

Drug: Traumeel S

Placebo Comparator: Receive placebo

Other: Placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California	United States	90095-1781
3	Children's Hospital of Orange County	Orange	California	United States	92868
4	Stanford Comprehensive Cancer Center at Stanford University Medical Center	Stanford	California	United States	94305
5	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
6	University of Florida Shands Cancer Center	Gainesville	Florida	United States	32610-0232
7	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
8	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136
9	All Children's Hospital	St. Petersburg	Florida	United States	33701
10	St. Joseph's Cancer Institute at St. Joseph's Hospital	Tampa	Florida	United States	33607
11	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
12	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	95813
13	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
14	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1083
15	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
16	Children's Hospital of New Orleans	New Orleans	Louisiana	United States	70118
17	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
18	Floating Hospital for Children at Tufts - New England Medical Center	Boston	Massachusetts	United States	02111
19	C.S. Mott Children's Hospital at University of Michigan	Ann Arbor	Michigan	United States	48109-0238
20	Spectrum Health Hospital - Butterworth Campus	Grand Rapids	Michigan	United States	49503-2560
21	Children's Hospitals and Clinics of Minneapolis	Minneapolis	Minnesota	United States	55404
22	University of Minnesota Medical Center & Children's Hospital - Fairview	Minneapolis	Minnesota	United States	55455
23	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
24	Siteman Cancer Center at Barnes-Jewish Hospital	St. Louis	Missouri	United States	63110
25	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York	United States	10461
26	Schneider Children's Hospital	New Hyde Park	New York	United States	11040
27	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York	United States	10032
28	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
29	New York Medical College	Valhalla	New York	United States	10595
30	Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106-5000
31	Oklahoma University Medical Center	Oklahoma City	Oklahoma	United States	73104
32	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
33	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
34	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
35	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas	United States	76104-9958
36	Methodist Children's Hospital of South Texas	San Antonio	Texas	United States	78229-3993
37	Children's Hospital of The King's Daughters	Norfolk	Virginia	United States	23507-1971
38	Prince of Wales Private Hospital	Randwick	New South Wales	Australia	2031
39	Westmead Institute for Cancer Research at Westmead Hospital	Westmead	New South Wales	Australia	2145
40	Princess Margaret Hospital for Children	Perth	Western Australia	Australia	6001
41	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario	Canada	K7L 3N6
42	Montreal Children's Hospital at McGill University Health Center	Montreal	Quebec	Canada	H3H 1P3
43	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
44	Chaim Sheba Medical Center	Tel Hashomer		Israel	52621

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