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

NCT00051441 | Completed Phase 3

• 1 other identifier: CR002491
• Study Type: interventional
• Target: 605
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effectiveness and safety of benzydamine hydrochloride 0.15% oral rinse to a vehicle oral rinse in the treatment of radiation-induced oral mucositis, and to compare the care normally used for radiation-induced oral mucositis to vehicle oral rinse to ensure that the vehicle does not have detrimental effects on the oral mucosa

Conditions

Stomatitis; Radiation Effects

Keywords

stomatitis; radiation effects

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the cumulative proportion of patients with severe mucositis (WHO mucositis score of at least 3) at a cumulative radiation dose of 5500 cGy

Secondary Outcomes (1)

• Secondary endpoints include cumulative RT to first use of an opioid for oral mucositis; cumulative RT to first ulceration; cumulative RT to first RT suspension due to oral mucositis

Interventions

Benzydamine Hydrochloride 0.15% Oral Rinse DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Karnofsky performance scale \>= 60%
• Diagnosis of pathologically confirmed malignancy involving one or more of the following sites: oral cavity, oropharynx extending down to the level of the supraglottic area, nasopharynx, maxillary sinus and parotid gland
• high risk for developing oral and/or oropharyngeal mucositis due to radiation to head and neck areas
• scheduled to receive a continuous course (eg, often six to eight weeks) of conventional or hyperfractionated external beam radiation for cancer of the head and neck region (subjects who had surgery prior to radiation are eligible) with or without concomitant chemotherapy
• at least two oral tissue sites (not including areas of previous lesions, 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, given in a single daily fraction of 180 to 220 cGy or twice daily fractions of 110 to 150 cGy

You may not qualify if:

• Known hypersensitivity to benzydamine HCl and/or any of the other components including alcohol, menthol, glycerin, flavoring agents, and preservatives
• oral or oropharyngeal mucositis present at the time of entry into the study
• treatment regimen consisting of noncontinuous radiation therapy
• received chemotherapy within 21 days of entry into the study as defined by initiation of radiation
• scheduled to receive or have received brachytherapy
• chronically being medicated for conditions other than tumor-related pain with oral and/or parenteral prescription steroids or analgesics
• use of chlorhexidine gluconate (Peridex), amifostine (Ethyol), topical antibiotics to the mouth (ie, tetracycline), topical steroids to the mouth, povidone iodine rinses, glutamine oral rinses, selective decontamination, and Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF)
• participated in an investigational study within 30 days prior to enrolling into the study where an experimental drug and/or product was taken
• not willing and/or able to take opioids for any reason
• cryotherapy (ie, ice chips or popsicles) prior to or during chemotherapy infusion

Sponsors & Collaborators

• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: lead
• Angelini: collaborator

Related Links

• Safety and 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

MeSH Terms

Conditions

Stomatitis

Interventions

Benzydamine; Mouthwashes

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

  McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2003
• First Posted: January 13, 2003
• Study Completion: February 1, 2005
• Last Updated: May 19, 2011

Record last verified: 2010-04