Overview

Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Criteria
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