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.

Condition	Treatment or Intervention	Phase
Salivary Gland Cancer lip and oral cavity cancer Head and Neck Cancer Oropharyngeal Cancer	Procedure: supportive care  Procedure: radioprotection  Procedure: complications of therapy assessment/management  Drug: infection prophylaxis/management  Behavior: supportive care/therapy  Procedure: quality-of-life assessment  Drug: iseganan HCl oral solution	Phase III

Further Study Details: 

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.

PROTOCOL 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 duration of 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Study chairs or principal investigators

Guy J.F. Juillard,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068810; UCLA-0008049; NCI-G01-2001; IBP-PG-015
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022373
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08