NCT00022373

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

February 4, 2004

Completed
Last Updated

October 15, 2014

Status Verified

November 1, 2001

First QC Date

August 10, 2001

Last Update Submit

October 14, 2014

Conditions

Head and Neck CancerOral Complications of Radiation TherapyRadiation Toxicity

Keywords

stage I nasopharyngeal cancerstage II nasopharyngeal cancerstage III nasopharyngeal cancerstage IV nasopharyngeal cancerstage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent salivary gland canceruntreated metastatic squamous neck cancer with occult primaryrecurrent metastatic squamous neck cancer with occult primarystage I lip and oral cavity cancerstage II lip and oral cavity cancerstage III lip and oral cavity cancerstage IV lip and oral cavity cancerstage I hypopharyngeal cancerstage II hypopharyngeal cancerstage III hypopharyngeal cancerstage IV hypopharyngeal cancerstage I oropharyngeal cancerstage II oropharyngeal cancerstage III oropharyngeal cancerstage IV oropharyngeal cancerradiation toxicityoral complications of radiation therapy

Interventions

iseganan HCl oral solutionDRUG
management of therapy complicationsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsRadiation InjuriesNasopharyngeal NeoplasmsSalivary Gland NeoplasmsMouth NeoplasmsHypopharyngeal NeoplasmsOropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsWounds and InjuriesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesSalivary Gland Diseases

Study Officials

  • Guy J. F. Juillard, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
SUPPORTIVE CARE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 10, 2001

First Posted

February 4, 2004

Study Start

December 1, 2000

Last Updated

October 15, 2014

Record last verified: 2001-11

Locations

US(1)