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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 Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD 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 site 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 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like 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 for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally 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. Subjects typically recieve the finest healthcare available 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. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern 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

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2. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery

3. Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer

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Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx

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