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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022373
Recruitment Status : Unknown
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 4, 2004
Last Update Posted : October 15, 2014
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oral Complications of Radiation Therapy Radiation Toxicity Drug: iseganan HCl oral solution Procedure: management of therapy complications Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : December 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022373

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Guy J. F. Juillard, MD Jonsson Comprehensive Cancer Center

Layout table for additonal information Identifier: NCT00022373     History of Changes
Other Study ID Numbers: CDR0000068810
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2004    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: November 2001
Keywords provided by National Cancer Institute (NCI):
stage I nasopharyngeal cancer
stage II nasopharyngeal cancer
stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
recurrent salivary gland cancer
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
stage I lip and oral cavity cancer
stage II lip and oral cavity cancer
stage III lip and oral cavity cancer
stage IV lip and oral cavity cancer
stage I hypopharyngeal cancer
stage II hypopharyngeal cancer
stage III hypopharyngeal cancer
stage IV hypopharyngeal cancer
stage I oropharyngeal cancer
stage II oropharyngeal cancer
stage III oropharyngeal cancer
stage IV oropharyngeal cancer
radiation toxicity
oral complications of radiation therapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases