- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00022373
Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
A Multinational, Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase III Clinical Trial to Determine the Efficacy and Safety of IB-367 Rinse in Reducing the Severity of Oral Mucositis in Patients Receiving Radiotherapy for Head and Neck Malignancy
RATIONALE: Iseganan hydrochloride may be effective in preventing or lessening oral mucositis in patients who are receiving radiation therapy for head and neck cancer. It is not yet known if iseganan hydrochloride is effective in preventing oral mucositis.
PURPOSE: Randomized phase III trial to determine the effectiveness of iseganan hydrochloride in preventing oral mucositis in patients who are receiving radiation therapy for head and neck cancer.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Compare the efficacy and safety of iseganan HCl oral solution vs placebo in patients undergoing radiotherapy with or without chemotherapy for head and neck cancer. II. Compare the effects of these treatments on mouth pain, ability to swallow, weight loss, and the distribution of oral mucositis in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to radiotherapy (conventional fractionating radiotherapy vs hyperfractionating or concurrent boost radiotherapy) and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 3 arms. Arm I: Patients rinse with iseganan HCl oral solution 6 times daily. Treatment continues for the duration of the scheduled radiotherapy. Arm II: Patients rinse with oral placebo 6 times daily. Treatment continues for the duration of the scheduled radiotherapy. Arm III: Patients receive standard-of-care supportive treatment. Oral cavity pain, ability to swallow, and weight loss are assessed twice weekly and on follow-up days 28 and 56. Patients are followed on days 28 and 56.
PROJECTED ACCRUAL: A total of 504 patients (252 for arm I, 168 for arm II, and 84 for arm III) will be accrued for this study.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed malignancy of the head and neck, including cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx, or salivary glands Undergoing or planning to undergo radiotherapy to the head and neck involving: Bilateral treatment with either conventional, hyperfractionated, or concurrent boost external beam radiotherapy Minimum total radiation dose of 60 Gy to at least 3 sites within the oral cavity Total scheduled administration of no more than 8 weeks No oral mucositis already present Ulceration related to head and neck malignancy or prior surgery allowed
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be able to orally rinse with study drug Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Concurrent chemotherapy allowed Endocrine therapy: No concurrent topical corticosteroids to oral cavity Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: At least 30 days since prior investigational agent for prevention and/or treatment of mucositis No prior participation in this study No concurrent topical anesthetics, such as lidocaine or dyclonine hydrochloride, within 30 minutes before or 15 minutes after study agent No concurrent oral rinses within 15 minutes of study agent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Guy J. F. Juillard, MD, Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- untreated metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- radiation toxicity
- stage II salivary gland cancer
- stage I nasopharyngeal cancer
- stage II nasopharyngeal cancer
- stage III hypopharyngeal cancer
- stage IV hypopharyngeal cancer
- stage III lip and oral cavity cancer
- stage IV lip and oral cavity cancer
- stage III nasopharyngeal cancer
- stage IV nasopharyngeal cancer
- stage III oropharyngeal cancer
- stage IV oropharyngeal cancer
- stage I hypopharyngeal cancer
- stage II hypopharyngeal cancer
- stage I lip and oral cavity cancer
- stage II lip and oral cavity cancer
- stage I oropharyngeal cancer
- stage II oropharyngeal cancer
- stage I salivary gland cancer
- oral complications of radiation therapy
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068810
- P30CA016042 (U.S. NIH Grant/Contract)
- UCLA-0008049
- IBP-PG-015
- NCI-G01-2001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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