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Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx Clinical research trials and Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx. Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx clinical trial. Human subjects often get the best healthcare available for their Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx
Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx
For Condition: Mouth Neoplasms
Status: Recruiting
Sponsor(s): McNeil Consumer & Specialty Pharmaceuticals ,
Synopsis: This study will test the effectiveness and safety of an investigational medication for mucositis (mouth sores/ulcers). Researchers are looking into whether the medication being studied will reduce the risk and duration of severe mucositis, as well as the interruptions in cancer treatment, that the condition sometimes causes. Currently, there is no FDA approved medication available to prevent the mouth sores or help them heal faster. To lessen the pain, people often rely on pain medications, mouth rinses, and a change in diet to less irritating foods and plenty of liquids. This study is called the ARISE study (Addressing Radiation Induced Side Effects).
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - A diagnosis of pathologically confirmed head and neck cancer of the oral cavity, oropharynx or nasopharynx. - Scheduled to receive a continuous course (e.g. 6-8 wks) of conventional or hyperfractionated external beam radiation with or without chemotherapy. - At least 2 oral tissue sites (not including areas of previous lesion, tumor, surgical resection or the lips) must be included in the RT treatment volume and planned to receive a total radiation dose of 5500 cGy or higher.
Total Enrollment: 750
Location and Contact Information:
Overall Study Official:
MaryC. Denisco, Study Director, McNeil Consumer & Specialty Pharmaceuticals
Beth Israel Medical Center *Recruiting*
New York City, New York, 10003
United States
Recruiting Kenneth Hu
Mobile Infirmary Medical Center *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting John Russell
University of California, San Diego, Radiation Oncology *Recruiting*
San Diego, California, 92103
United States
Recruiting Francisco Pardo
Medical Office Plaza *Recruiting*
Lubbock, Texas, 79415
United States
Recruiting Joehassin Cordero
Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Donald Coleman
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting Burton Speiser
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting George Taybos
Froedtert Memorial Lutheran Hospital - Department of Radiation Oncology East Clinic *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Christopher Schultz
Norwalk Hospital Radiation Oncology *Recruiting*
Norwalk, Connecticut, 06856
United States
Recruiting Pradip Pathare
University of Alabama *Recruiting*
Birmingham, Alabama, 35249-6832
United States
Recruiting Roger Ove
Fairview-University Medical Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Chung Lee
University of Kentucky Medical Center *Recruiting*
Lexington, Kentucky, 40536
United States
Recruiting Mahesh Kudrimoti
James Graham Brown Cancer Center *Recruiting*
Louisville, Kentucky, 40202-3229
United States
Recruiting Zafrulla Khan
North Mississippi Medical Center *Recruiting*
Tupelo, Mississippi, 38801
United States
Recruiting Bert Duncan
Baptist Hospital *Recruiting*
Pensacola, Florida, 32501-6339
United States
Recruiting Joseph Weaver
Cancer Treatment Services *Recruiting*
Buffalo, New York, 14214
United States
Recruiting Dhiren Shah
Summa Health System *Recruiting*
Akron, Ohio, 44304
United States
Recruiting William Demas
Medical College of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19129
United States
Recruiting Lydia Komarnicky
Therapeutic Radiology 1-277 Fairview-Univeristy Medical Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Chung Lee
Enloe Medical Center - Cancer Center *Recruiting*
Chico, California, 95926
United States
Recruiting Michael Baird
The University of Texas M.D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Adam Garden
Our Lady of Lourdes Regional Medical Center *Recruiting*
Lafayette, Louisiana, 70502
United States
Recruiting Andrew Harwood
Arizona Oncology Services *Recruiting*
Apache Junction, Arizona, 85220
United States
Recruiting Burton Speiser
Harper University Hospital *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Donald Coleman
The University of Texas Health Science Center At San Antonio *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Spencer Redding
West Virginia University *Recruiting*
Morgantown, West Virginia, 26506
United States
Recruiting Robert Stuchell
Discovery Alliance, Inc. Mobile Infirmary Medical Center *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting John Russell
Peninsula Regional Medical Center *Recruiting*
Salisbury, Maryland, 21801
United States
Recruiting Scott Edwards
University of Virginia - Department of Radiation Oncology *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Paul Read
St. Joseph's Hospital and Medical Center *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting Burton Speiser
Texas Tech University HSC *Recruiting*
Lubbock, Texas, 79415
United States
Recruiting Joehassin Cordero
Florida Cancer Institute *Recruiting*
New Port Richey, Florida, 34652
United States
Recruiting Lawrence Hochmann
Strong Memorial Hospital *Recruiting*
Rochester, New York, 14642
United States
Recruiting Gene Watson
University of Texas Soutwestern Medical Center, Dept. of Otolaryngology - Head & Neck Surgery *Recruiting*
Dallas, Texas, 75390-9035
United States
Recruiting John Truelson
Radiation Oncology Service *Recruiting*
Shreveport, Louisiana, 71103
United States
Recruiting Stanford Katz
Boston Medical Center, Department of Radiation Oncology *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Alan Hartford
Havasu Regional Medical Center *Recruiting*
Lake Havasu City, Arizona, 86403
United States
Recruiting Gilles LaChance
Mount Nittany Medical Center *Recruiting*
State College, Pennsylvania, 16803
United States
Recruiting Roby Lal
Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232
United States
Recruiting Peter Lockhard
Medical College of South Carolina, Department of Radiation Oncology *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Anand Sharma
VA Palo Alto Health Care System *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Quynh-Thu Le
Arizona Oncology Services *Recruiting*
Mesa, Arizona, 85021
United States
Recruiting Burton Speiser
Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5302
United States
Recruiting Quynh-Thu Le
University of Connecticut Health Center - Dept of Oral Diagnosis *Recruiting*
Farmington, Connecticut, 06030-1605
United States
Recruiting Douglas Peterson
Southeast Alabama Medical Center *Recruiting*
Dothan, Alabama, 36301
United States
Recruiting Steven Stokes
Loyola University Medical Center (Maguire Building - Oral Health) *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Diane Talentowski
UCSD Medical Center Department of Radiation Oncology *Recruiting*
San Diego, California, 92103-8757
United States
Recruiting Francisco Pardo
Hill Radiation Oncology *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Chung Chung
Hahnemann University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19102
United States
Recruiting Lydia Komarnicky
21st Century Oncology *Recruiting*
Ft. Myers, Florida, 33901
United States
Recruiting Michael Katin
Medical College of Georgia *Recruiting*
Augusta, Georgia, 30912
United States
Recruiting Wayne Herman
University of Michigan Medical School, Department of Radiation Oncology *Recruiting*
Ann Arbor, Michigan, 48109
United States
Recruiting Avraham Eisbruch
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Judith Figura
Southwest Cancer Center *Recruiting*
Lubbock, Texas, 79415
United States
Recruiting Joehassin Cordero
Providence Everett Medical Center Cancer Institute *Recruiting*
Everett, Washington, 98206
United States
Recruiting William Wisbeck
Arizona Oncology Services *Recruiting*
Scottsdale, Arizona, 85260
United States
Recruiting Burton Speiser
Arizona Oncology Services *Recruiting*
Phoenix, Arizona, 85015
United States
Recruiting Burton Speiser
North Carolina Clinical Cancer Center *Recruiting*
Chapel Hill, North Carolina, 27599-7450
United States
Recruiting Mark Kutcher
JFK Cancer Center *Recruiting*
Lake Worth, Florida, 33461-4710
United States
Recruiting Jerome Spunberg
Evanston Northwestern Healthcare Evanston Hospital *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Harry Staffileno
John B. Amos Cancer Center *Recruiting*
Columbus, Georgia, 31902
United States
Recruiting Doug Ciuba
North Mississippi Medical Center Cancer Center Radiation Oncology *Recruiting*
Tupelo, Mississippi, 38801
United States
Recruiting Bert Duncan
Long Island Jewish Medical Center *Recruiting*
New Hyde Park, New York, 11040
United States
Recruiting Jed Pollack
State University of New York at Stony Brook *Recruiting*
Stony Brook, New York, 11794-7028
United States
Recruiting Allen Meek
UMDNJ-University Hospital Radiation Oncology Dept. *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting John Jandinski
Medical College of South Carolina Department of Radiation Oncology *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Anand Sharma
Cancer Therapy and Research Center *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Spencer Redding
Roswell Park Cancer Institute Dental Clinic *Recruiting*
Buffalo, New York, 14263
United States
Recruiting Maureen Sullivan
LDS Hospital Radiation Oncology *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting John Thomson
Saint Agnes Medical Center, Cancer Center *Recruiting*
Fresno, California, 93720
United States
Recruiting William Podelsky
Temple University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19140
United States
Recruiting Curtis Miyamoto
Hospital of the University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Martin Greenberg
Ear, Nose & Throat SpecialtyCare *Recruiting*
Minneapolis, Minnesota, 55404
United States
Recruiting Merril Biel
Texas ENT Consultants PLLC *Recruiting*
Houston, Texas, 77030
United States
Recruiting Eugene Alford
Alta Bates Medical Center *Recruiting*
Berkeley, California, 94709
United States
Recruiting Elizabeth Tapen
St. Joseph's Mercy Cancer Center *Recruiting*
Hot Springs, Arkansas, 71913
United States
Recruiting David Pruitt
SUNY Upstate Medical Center Cancer Institute *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Chung Chung
University of Wisconsin Hospital and Clinics *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Paul Harari
Washington Hospital Center Washington Cancer Institute *Recruiting*
Washington D.C., District of Columbia, 20010
United States
Recruiting Robert White
Cardinal Bernardin Cancer Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Diane Talentowski
Graduate Hospital *Recruiting*
Philadelphia, Pennsylvania, 19146
United States
Recruiting Lydia Komarnicky
Batavia Radiation Oncology Center *Recruiting*
Batavia, New York, 14020
United States
Recruiting Kevin Mudd
Johns Hopkins Medical Center Department of Otolaryngology Head and Neck Surgery *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting James Scuibba
Alta Bates Comprehensive Cancer Center *Recruiting*
Berkeley, California, 94704
United States
Recruiting Elizabeth Tapen
Loyola University Medical Center (Foster G. McGraw Hospital) *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Diane Talentowski
Additional Information:
Study ID Numbers: 00-107;
Study Start Date: December 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051441
Other Mouth Neoplasms Studies:
1. Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
2. Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx
Related Studies:
Other Mouth Neoplasms Clinical Trials
Other California Clinical Trials
Other Stanford Clinical Trials
Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx
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