Ranitidine Oral Syrup |
Zantac Syrup |
Clinical Trial: Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
This study is currently recruiting patients.
Purpose
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: Randomized clinical trial to compare the effectiveness of Traumeel S with that of a placebo in preventing or reducing the pain of mucositis in young patients who are receiving chemotherapy with or without total-body irradiation before undergoing stem cell transplantation.
| Condition | Treatment or Intervention |
|---|---|
| Cancer oral complications of cancer and cancer therapy | Drug: Traumeel S Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: complications of therapy assessment/management Procedure: supportive care/therapy |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Randomized Study of Traumeel® S for the Prevention and Treatment of Mucositis in Pediatric Patients Undergoing Hematopoietic 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.
Eligibility
Ages Eligible for Study: 3 Years - 25 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Alabama
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35233, United States; Recruiting
University of South Alabama Cancer Research Institute, Mobile, Alabama, 36604, United States; Recruiting
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
Phoenix Children's Hospital, Phoenix, Arizona, 85016, United States; Recruiting
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
Children's Hospital and Health Center, San Diego, San Diego, California, 92123-4282, United States; Recruiting
Children's Hospital and Research Center at Oakland, Oakland, California, 94609-1809, United States; Recruiting
Children's Hospital Central California, Madera, California, 93638-8762, United States; Recruiting
Children's Hospital Los Angeles, Los Angeles, California, 90027-0700, United States; Recruiting
Children's Hospital of Orange County, Orange, California, 92868, United States; Recruiting
General Robert Huyser Cancer Center at David Grant Medical Center, Travis Air Force Base, California, 94535, United States; Recruiting
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, 90801-1428, United States; Recruiting
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
Kaiser Permanente Medical Center - Sacramento, Sacramento, California, 95825, United States; Recruiting
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, 95051-5386, United States; Recruiting
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego, California, 92120, United States; Recruiting
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, 92354, United States; Recruiting
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, 94304, United States; Recruiting
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting
Santa Barbara Cottage Hospital, Santa Barbara, California, 93102, United States; Recruiting
Southern California Permanente Medical Group, Downey, California, 90242, United States; Recruiting
Sutter Cancer Center, Sacramento, California, 95816, United States; Recruiting
UCSF Comprehensive Cancer Center, San Francisco, California, 94143, United States; Recruiting
Colorado
Children's Hospital Cancer Center, Denver, Colorado, 80218, United States; Recruiting
Presbyterian - St. Luke's Medical Center, Denver, Colorado, 80218, United States; Recruiting
Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, 06360-7106, United States; Recruiting
Yale Comprehensive Cancer Center, New Haven, Connecticut, 06520-8064, United States; Recruiting
Delaware
Alfred I. duPont Hospital for Children, Wilmington, Delaware, 19899, United States; Recruiting
District of Columbia
Children's National Medical Center, Washington, District of Columbia, 20010-2970, United States; Recruiting
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting
Florida
All Children's Hospital, St. Petersburg, Florida, 33701, United States; Recruiting
Baptist-South Miami Regional Cancer Program, Miami, Florida, 33176-2197, United States; Recruiting
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
Children's Hospital of Southwest Florida, Fort Myers, Florida, 33908, United States; Recruiting
Florida Hospital Cancer Institute, Orlando, Florida, 32804, United States; Recruiting
Jackson Memorial Hospital, Miami, Florida, 33136, United States; Recruiting
Joe DiMaggio Children's Hospital at Memorial, Hollywood, Florida, 33021, United States; Recruiting
Miami Children's Hospital, Miami, Florida, 33155, United States; Recruiting
Nemours Children's Clinic, Jacksonville, Florida, 32207, United States; Recruiting
Nemours Children's Clinic-Orlando, Orlando, Florida, 32806, United States; Recruiting
Sacred Heart Children's Hospital, Pensacola, Florida, 32504, United States; Recruiting
St. Joseph's Children's Hospital, Tampa, Florida, 33677-4227, United States; Recruiting
St. Mary's Hospital, West Palm Beach, Florida, 33407, United States; Recruiting
University of Florida Shands Cancer Center, Gainesville, Florida, 32610-0296, United States; Recruiting
Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta, Georgia, 30342, United States; Recruiting
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, 31405, United States; Recruiting
MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia, 30912-4000, United States; Recruiting
Medical Center of Central Georgia, Macon, Georgia, 31201, United States; Recruiting
Hawaii
Cancer Research Center of Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Tripler Army Medical Center, Honolulu, Hawaii, 96859-5000, United States; Recruiting
Idaho
Mountain States Tumor Institute - Boise, Boise, Idaho, 83712, United States; Recruiting
Illinois
Advocate Hope Children's Hospital, Oak Lawn, Illinois, 60453, United States; Recruiting
Children's Memorial Hospital - Chicago, Chicago, Illinois, 60614, United States; Recruiting
Lutheran General Cancer Care Center, Park Ridge, Illinois, 60068-1174, United States; Recruiting
Rush University Medical Center, Chicago, Illinois, 60612, United States; Recruiting
Saint Jude Midwest Affiliate, Peoria, Illinois, 61637, United States; Recruiting
Southern Illinois University School of Medicine, Springfield, Illinois, 62794-9658, United States; Recruiting
University of Chicago Cancer Research Center, Chicago, Illinois, 60601, United States; Recruiting
University of Illinois Medical Center, Chicago, Illinois, 60612, United States; Recruiting
Indiana
Riley Children Cancer Center at Riley Hospital for Children, Indianapolis, Indiana, 46202-5225, United States; Recruiting
St. Vincent Hospitals and Health Care Centers, Indianapolis, Indiana, 46260, United States; Recruiting
Iowa
Blank Children's Hospital, Des Moines, Iowa, 50308, United States; Recruiting
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, 50309, United States; Recruiting
Kansas
Wesley Medical Center, Wichita, Kansas, 67214, United States; Recruiting
Kentucky
Kosair Children's Hospital, Louisville, Kentucky, 40202-3830, United States; Recruiting
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0284, United States; Recruiting
Louisiana
Children's Hospital of New Orleans, New Orleans, Louisiana, 70118, United States; Recruiting
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, 70121, United States; Recruiting
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Maine
CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, 04401, United States; Recruiting
Maine Children's Cancer Program, Scarborough, Maine, 04074-9308, United States; Recruiting
Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, 21215, United States; Recruiting
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201-1595, United States; Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-2410, United States; Recruiting
Walter Reed Army Medical Center, Silver Spring, Maryland, 20910, United States; Recruiting
Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts, 01107, United States; Recruiting
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
Floating Hospital for Children, Boston, Massachusetts, 02111, United States; Recruiting
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Michigan
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, 48910, United States; Recruiting
Bronson Methodist Hospital, Kalamazoo, Michigan, 49007-5364, United States; Recruiting
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Children's Hospital of Michigan, Detroit, Michigan, 48201, United States; Recruiting
DeVos Children's Hospital, Grand Rapids, Michigan, 49503, United States; Recruiting
Hurley Medical Center, Flint, Michigan, 48503, United States; Recruiting
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0914, United States; Recruiting
Van Elslander Cancer Center at St. John Hospital and Medical Center, Detroit, Michigan, 48236, United States; Recruiting
William Beaumont Hospital - Royal Oak, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Minnesota
Children's Hospitals and Clinics - Minneapolis/St. Paul, Minneapolis, Minnesota, 55404, United States; Recruiting
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, 55805, United States; Recruiting
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
Missouri
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, 63104, United States; Recruiting
Children's Mercy Hospital, Kansas City, Missouri, 64108, United States; Recruiting
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
St. Louis Children's Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
Nebraska
Children's Hospital of Omaha, Omaha, Nebraska, 68114, United States; Recruiting
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-2168, United States; Recruiting
Nevada
Sunrise Hospital and Medical Center, Las Vegas, Nevada, 89109, United States; Recruiting
New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States; Recruiting
New Jersey
Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States; Recruiting
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
Newark Beth Israel Medical Center, Newark, New Jersey, 07112-2094, United States; Recruiting
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, 07503, United States; Recruiting
Valerie Fund Children's Center at Atlantic Health, Summit, New Jersey, 07901, United States; Recruiting
New Mexico
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, 87131, United States; Recruiting
New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting
Brookdale University Hospital and Medical Center, Brooklyn, New York, 11212, United States; Recruiting
Brooklyn Hospital Center, Brooklyn, New York, 11201-5493, United States; Recruiting
Cancer Center of Albany Medical Center, Albany, New York, 12208, United States; Recruiting
Comprehensive Cancer Center at Maimonides Medical Center, Brooklyn, New York, 11219, United States; Recruiting
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York, 11794, United States; Recruiting
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Mount Sinai School of Medicine, New York, New York, 10029, United States; Recruiting
New York Medical College, Valhalla, New York, 10595, United States; Recruiting
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Schneider Children's Hospital, New Hyde Park, New York, 11042, United States; Recruiting
SUNY Downstate Medical Center, Brooklyn, New York, 11203, United States; Recruiting
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
North Carolina
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, 28232-2861, United States; Recruiting
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1081, United States; Recruiting
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital, Greenville, North Carolina, 27858-4354, United States; Recruiting
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599, United States; Recruiting
Mission Hospitals, Asheville, North Carolina, 28801, United States; Recruiting
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, 28233, United States; Recruiting
North Dakota
Dakota Cancer Institute at Innovis Health - Dakota Clinic, Fargo, North Dakota, 58103-4940, United States; Recruiting
Ohio
Children's Hospital Medical Center of Akron, Akron, Ohio, 44308-1062, United States; Recruiting
Children's Medical Center - Dayton, Dayton, Ohio, 45404, United States; Recruiting
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229-3039, United States; Recruiting
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States; Recruiting
Columbus Children's Hospital, Columbus, Ohio, 43205-2696, United States; Recruiting
Forum Health-Tod Childrens Hospital, Youngstown, Ohio, 44501, United States; Recruiting
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, 44106-5065, United States; Recruiting
St. Vincent Mercy Medical Center, Toledo, Ohio, 43608, United States; Recruiting
Toledo Children's Hospital, Toledo, Ohio, 43601, United States; Recruiting
Oklahoma
CCOP - Oklahoma, Tulsa, Oklahoma, 74136, United States; Recruiting
Children's Hospital at Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, 74136, United States; Recruiting
Oregon
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Doernbecher Children's Hospital at Oregon Health & Science University, Portland, Oregon, 97239-3098, United States; Recruiting
Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon, 97227, United States; Recruiting
Pennsylvania
Children's Hospital at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States; Recruiting
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Geisinger Medical Center, Danville, Pennsylvania, 17822-1320, United States; Recruiting
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, 19134-1095, United States; Recruiting
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
South Carolina
Children's Hospital of Greenville Hospital System, Greenville, South Carolina, 29605, United States; Recruiting
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425-0721, United States; Recruiting
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, 29203, United States; Recruiting
South Dakota
Avera Cancer Institute, Sioux Falls, South Dakota, 57105-1080, United States; Recruiting
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, 57117-5039, United States; Recruiting
Tennessee
East Tennessee Children's Hospital, Knoxville, Tennessee, 37901, United States; Recruiting
East Tennessee State University Cancer Center at Johnson City Medical Center, Johnson City, Tennessee, 37614-0622, United States; Recruiting
St. Jude Children's Research Hospital, Memphis, Tennessee, 38105-2794, United States; Recruiting
Vanderbilt Children's Hospital, Nashville, Tennessee, 37232-6310, United States; Recruiting
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Center for Cancer Prevention and Care at Scott and White Clinic, Temple, Texas, 76508, United States; Recruiting
Children's Hospital of Austin, Austin, Texas, 78701, United States; Recruiting
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, 76104, United States; Recruiting
Covenant Children's Hospital, Lubbock, Texas, 79410, United States; Recruiting
MBCCOP - South Texas Pediatrics, San Antonio, Texas, 78229-3900, United States; Recruiting
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4009, United States; Recruiting
Medical City Dallas Hospital, Dallas, Texas, 75230, United States; Recruiting
Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio, Texas, 78229-3902, United States; Recruiting
San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base, Texas, 78236, United States; Recruiting
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390-9063, United States; Recruiting
Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, 79106, United States; Recruiting
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78207, United States; Recruiting
University of Texas Medical Branch, Galveston, Texas, 77555-0209, United States; Recruiting
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112, United States; Recruiting
Vermont
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting
Virginia
Cancer Center at the University of Virginia, Charlottesville, Virginia, 22908, United States; Recruiting
Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke, Virginia, 24029, United States; Recruiting
Children's Hospital of the King's Daughters, Norfolk, Virginia, 23507, United States; Recruiting
INOVA Fairfax Hospital, Falls Church, Virginia,
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: March 28, 2005
Record first received: April 7, 2004
ClinicalTrials.gov Identifier: NCT00080873
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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