|
Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx Clinical research trials and Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx. Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx clinical trial. Human subjects often receive the most effective healthcare possible for their Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx
Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx
For Condition: Nasopharyngeal Cancer,oral complications of chemotherapy and head and neck radiation,Oropharyngeal Cancer,lip and oral cavity cancer
Status: Recruiting
Sponsor(s): McNeil Consumer & Specialty Pharmaceuticals ,
Synopsis: RATIONALE: Benzydamine may lessen the severity of radiation-induced (caused by radiation therapy) oral mucositis. It is not yet known whether benzydamine is more effective than standard therapy in treating radiation-induced oral mucositis. PURPOSE: Randomizedphase III trial to compare the effectiveness of benzydamine with that of standard therapy in treating radiation-induced oral mucositis in patients who are undergoing radiation therapy for cancer of the oral cavity, oropharynx, and/or nasopharynx.
Details: OBJECTIVES: - Compare the efficacy and safety of benzydamine hydrochloride oral rinse vs vehicle oral rinse to treat radiation-induced oral mucositis in patients with cancer of the oral cavity, oropharynx, and/or nasopharynx undergoing radiotherapy. - Compare the effects on oral mucosa in patients treated with standard of care vs vehicle oral rinse. OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Patients are stratified according to participating center and treatment regimen (radiotherapy alone vs radiotherapy with concurrent chemotherapy). Patients are randomized to 1 of 3 treatment arms. All patients undergo radiotherapy beginning after the first dose of study therapy. - Arm I: Patients receive benzydamine hydrochloride oral rinse every 2-3 hours while awake (4-8 doses per day) and practice standard of care treatment guidelines comprising tooth brushing with a soft bristle toothbrush at least twice daily, flossing at least once daily, and using daily home fluoride treatments. - Arm II: Patients receive vehicle oral rinse every 2-3 hours while awake (4-8 doses per day) and practice standard of care treatment guidelines. - Arm III: Patients practice standard of care treatment guidelines. In all arms, treatment continues until 2 weeks after the completion of radiotherapy. PROJECTED ACCRUAL: A total of 750 patients (300 for the benzydamine hydrochloride oral rinse arm, 300 for the vehicle oral rinse arm, and 150 for the standard of care arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed cancer of the oral cavity, oropharynx, and/or nasopharynx - Unknown primary tumor site allowed provided squamous cell carcinoma is histologically confirmed on cervical lymph node biopsy - At high risk for developing oral and/or oropharyngeal mucositis due to head and neck radiotherapy - Scheduled to undergo a continuous course (e.g., 6-8 weeks) of conventional or hyperfractionated external beam radiotherapy with or without concurrent chemotherapy - Planning to receive a total radiation dose 5,500 cGy, administered in a single daily fraction of 180-220 cGy or twice daily fractions of 110-150 cGy - Intensity-modulated radiotherapy allowed - No prior or concurrent brachytherapy - At least 2 oral tissue sites must be included in the radiotherapy treatment volume, not including areas of prior lesions, tumor, surgical resection, or the lips - No oral or oropharyngeal mucositis present at study entry PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 3 months before, during, and for 3 months after study participation - Willing and able to take opioids - No other significant medical history or condition that would preclude study participation - No known hypersensitivity to benzydamine hydrochloride and/or any of the other components, including alcohol, menthol, glycerin, flavoring agents, or preservatives PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent sargramostim (GM-CSF) Chemotherapy - See Disease Characteristics - More than 1 month since prior chemotherapy Endocrine therapy - No concurrent chronic oral and/or parenteral steroids for conditions other than tumor-related pain control - No concurrent topical steroids to the mouth Radiotherapy - See Disease Characteristics Surgery - Prior surgery allowed Other - More than 30 days since prior participation in an investigational study where an experimental drug or product was taken - No prior participation in this study - No other concurrent investigational drugs - No concurrent chronic treatment with analgesics or nonsteroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors and over-the-counter medications being used beyond their labeled directions, for conditions other than tumor-related pain control - No concurrent cryotherapy (e.g., ice chips or popsicles) before or during chemotherapy administration - No concurrent administration of any of the following: - Chlorhexidine gluconate (Peridex®) - Oral pilocarpine (Salagen®) - Amifostine (Ethyol®) - Sucralfate slurry (Carafate®) - Topical antibiotics to the mouth (e.g., tetracycline) - Diphenhydramine (Benadryl®) - Povidone iodine rinses - Glutamine oral rinses - Selective decontamination - "Magic mouthwash" containing any of the above or any other medication without an approved indication for topical oral use except liquid antacid formulations (e.g., Maalox®, Mylanta®, or generic equivalents) - No other concurrent mouthwash or any other drugs or agents to aid in oral hygiene - Viscous lidocaine, oral antifungal drugs, bland oral rinses, and Gelclair are allowed, but not within 1 hour before or 30 minutes after administration of double-blind oral rinses
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DennisParenti, Principal Investigator, McNeil Consumer & Specialty Pharmaceuticals
University of Connecticut Cancer Center at University of Connecticut Health Center *Recruiting*
Farmington, Connecticut, 06360-1605
United States
Recruiting Douglas Peterson 860-679-2952
Cancer Research Center at Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Alan Hartford 617-638-7070
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Donald Coleman 313-745-9300
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting George Taybos 601-984-6060
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Anand Sharma 843-792-3533
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-3236
United States
Recruiting Paul Harari 608-263-8500
Mobile Infirmary Medical Center *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting John Russell 251-435-4419
Cranial Pain Research *Recruiting*
Tucson, Arizona, 85711
United States
Recruiting Theodore Kiersch 520-790-7246
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536
United States
Recruiting Mahesh Kudrimoti 859-323-6486
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Martin Greenberg 215-898-6627
Saint Joseph's Mercy Cancer Center *Recruiting*
Hotspring, Arkansas, 71913
United States
Recruiting David Pruitt 501-622-2100
Willis-Knighton Cancer Center at Willis-Knighton Medical Center *Recruiting*
Shreveport, Louisiana, 71103-3951
United States
Recruiting Sanford Katz 318-212-4639
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14612
United States
Recruiting Gene Watson 585-275-1762
Florida Cancer Institute *Recruiting*
New Port Richey, Florida, 34652
United States
Recruiting Lawrence Hochman 727-842-8411
Medical College of Georgia *Recruiting*
Augusta, Georgia, 30912-6276
United States
Recruiting Wayne Herman 706-721-2607
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0922
United States
Recruiting Avraham Eisbruch 313-936-9337
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Paul Read 434-924-5191
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5302
United States
Recruiting Quynh-Thu Le 650-498-5032
Medical Center/John B. Amos Community Cancer Center *Recruiting*
Columbus, Georgia, 31901
United States
Recruiting Douglas Ciuba 706-660-6404
UMDNJ University Hospital *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting John Jandinski 973-972-5066
Gabrail Cancer Center - Dover Office *Recruiting*
Dover, Ohio, 44622
United States
Recruiting Nashat Gabrail 330-365-2135 ext. 204
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Adam Garden 713-563-2321
Montgomery Cancer Center *Recruiting*
Montgomery, Alabama, 36106-3657
United States
Recruiting Robert Franklin 205-260-2000
Enloe Cancer Center at Enloe Medical Center *Recruiting*
Chico, California, 95926
United States
Recruiting Michael Baird 530-332-3808
Washington Hospital Center *Recruiting*
Washington D.C., District of Columbia, 20010
United States
Recruiting Robert White 202-877-3925
Baptist Hospital- Pensacola *Recruiting*
Pensacola, Florida, 32522
United States
Recruiting Joseph Weaver 850-469-2200
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting John Thomson 801-408-1146
Schiffler Cancer Center *Recruiting*
Wheeling, West Virginia, 26003
United States
Recruiting Jon Pollock 304-243-3490
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Diane Talentowski 708-216-3625
University of Illinois at Chicago Health Sciences Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Joel Epstein 312-996-7480
State University of New York Health Science Center at Brooklyn *Recruiting*
Brooklyn, New York, 11203
United States
Recruiting Marvin Rotman 718-270-2181
Blumenthal Cancer Center at Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232
United States
Recruiting Peter Lockhart 704-355-4841
Southwest Cancer Center at UMC *Recruiting*
Lubbock, Texas, 79415
United States
Recruiting Joehassin Cordero 806-743-4115
Beth Israel Medical Center - Philipps Ambulatory Care Center *Recruiting*
New York City, New York, 10003
United States
Recruiting Kenneth Hu 212-844-2022
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263
United States
Recruiting Maureen Sullivan 716-845-5970
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205-7199
United States
Recruiting Randall Breau 501-686-5140
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Guy Juillard 310-825-7145
University of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Chung Lee 612-273-6700
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5097
United States
Recruiting Kulbir Sidhu 215-955-8619
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9035
United States
Recruiting John Truelson 214-648-3706
Radiation Oncology Group, P.A. *Recruiting*
Lake Worth, Florida, 33461
United States
Recruiting Jerome Spunberg 561-964-2662
Whittingham Cancer Center *Recruiting*
Norwalk, Connecticut, 06856
United States
Recruiting Pradip Pathare 203-852-2713
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Chung-Taik Chung 315-464-5276
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35249-6832
United States
Recruiting Roger Ove 205-975-0224
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting John Holland 503-494-1617
North Mississippi Medical Center Cancer Center *Recruiting*
Tupelo, Mississippi, 38801
United States
Recruiting Elbert Duncan 662-377-4074
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-5671
United States
Recruiting A.J. Cmelak 615-322-2555
St. Joseph's Hospital and Medical Center *Recruiting*
Phoenix, Arizona, 85001-2071
United States
Recruiting Burton Speiser 602-406-3170
Alta Bates Comprehensive Cancer Center *Recruiting*
Berkeley, California, 94704
United States
Recruiting Elizabeth Tapen 510-204-5311
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0658
United States
Recruiting Francisco Pardo 619-543-5305
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting James Sciubba 410-955-2083
Akron City Hospital *Recruiting*
Akron, Ohio, 44304
United States
Recruiting William Demas 330-375-3557
Temple University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19140
United States
Recruiting Curtis Miyamoto 215-707-4233
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284
United States
Recruiting Spencer Redding 210-567-3656
Froedtert Memorial Lutheran Hospital *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Christopher Schultz 414-805-4380
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201-1781
United States
Recruiting Harry Staffileno 847-570-2000
Batavia Radiation Oncology *Recruiting*
Batavia, New York, 14020
United States
Recruiting Kevin Mudd 716-344-3050
Long Island Cancer Center at Stony Brook University Hospital *Recruiting*
Stony Brook, New York, 11794-7028
United States
Recruiting Allen Meek 631-444-2200
Discovery Alliance, Incorporated *Recruiting*
Houston, Texas, 77030
United States
Recruiting Eugene Alford 713-532-3223
James Graham Brown Cancer Center at University of Louisville *Recruiting*
Louisville, Kentucky, 40202-3267
United States
Recruiting Zafrulla Khan 505-852-6132
Hickman Cancer Center at Bixby Medical Center *Recruiting*
Adrian, Michigan, 49221
United States
Recruiting Harold Johnson 517-265-0292
Ear, Nose, and Throat Specialty Care of Minnesota, P.A. *Recruiting*
Minneapolis, Minnesota, 55404
United States
Recruiting Merrill Biel 612-871-1144
Cancer Treatment Services *Recruiting*
Buffalo, New York, 14214
United States
Recruiting Dhiren Shah 716-838-3880
Gabrail Cancer Center - Canton Office *Recruiting*
Canton, Ohio, 44718
United States
Recruiting Nashat Gabrail 330-492-3345 ext. 208
Hahnemann University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19102
United States
Recruiting Lydia Komarnicky-Kocher 215-762-4984
Providence Everett Medical Center - Pacific Campus *Recruiting*
Everett, Washington, 98206
United States
Recruiting William Wisbeck 425-258-7255
Additional Information:
Study ID Numbers: CDR0000355160; MCSP-00-0107
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080769
Other Lip And Oral Cavity Cancer Studies:
1. Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat
2. Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx
3. Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia
Related Studies:
Other lip and oral cavity cancer Clinical Trials
Other Illinois Clinical Trials
Other Evanston Clinical Trials
Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx
|
|
|
|
|
|
|
|