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



Status:Completed
Conditions:Cancer, Cancer, Cancer, Brain Cancer, Blood Cancer, Lymphoma, Kidney Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:3 - 25
Updated:4/21/2016
Start Date:April 2004
End Date:January 2011

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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.

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.

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
We found this trial at
38
sites
807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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800 Washington St # 314
Boston, Massachusetts 02111
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1300 Morris Park Avenue
Bronx, New York 10461
718.430.2302
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Albert Einstein Cancer Center...
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Bronx, NY
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
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Charleston, SC
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas From its...
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1376 Mowry Road
Gainesville, Florida 32610
(352) 273-8010
University of Florida Shands Cancer Center We are the University of Florida Health Cancer Center
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701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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Minneapolis, Minnesota 55404
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New Hyde Park, New York 11042
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
Methodist Children's Hospital of South Texas Methodist Children
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750 E Adams St
Syracuse, New York 13210
(315) 464-5540
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
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3001 W Dr Martin L King Jr
Tampa, Florida 33607
(813) 870-4123
St. Joseph's Cancer Institute at St. Joseph's Hospital St. Joseph's Hospital is known for its...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Grand Rapids, Michigan 49503
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Indianapolis, Indiana 46202
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3901 Rainbow Boulevard
Kansas City, Kansas 66160
913.588.1227#sthash.z9pLd
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center The Kansas Masons...
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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New Orleans, Louisiana 70118
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Oklahoma City, Oklahoma 73104
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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Randwick, New South Wales 2031
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501 6th Avenue South
St. Petersburg, Florida 33701
(727) 898-7451
All Children's Hospital All Children's Hospital provides expert pediatric care for children and families from...
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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