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Iseganan for Oral Mucositis in Head and Neck Cancer

Phase 3
Waitlist Available
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No oral mucositis already present
Histologically confirmed malignancy of the head and neck, including cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx, or salivary glands
Must not have
Age under 18
Concurrent use of topical corticosteroids to oral cavity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is looking at whether iseganan hydrochloride can help prevent oral mucositis (mouth sores) in people receiving radiation therapy for head and neck cancer.

Who is the study for?
This trial is for adults with confirmed head and neck cancer, who will receive a radiation dose of at least 60 Gy to parts of the oral cavity. They must be able to rinse their mouth with the study drug, not have current mucositis or be pregnant/nursing, and agree to use contraception.
What is being tested?
The effectiveness of Iseganan hydrochloride in preventing oral mucositis (painful sores in the mouth) caused by radiation therapy for head and neck cancer is being tested. This phase III trial randomly assigns patients to either receive this potential preventive treatment or not.
What are the potential side effects?
While specific side effects are not listed here, generally such interventions might cause irritation or discomfort in the mouth, changes in taste sensation, possible allergic reactions, or interact with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have mouth sores.
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My cancer is in my head or neck area, like my mouth or throat.
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I am receiving or planning to receive radiotherapy on both sides of my head and neck.
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I have received at least 60 Gy of radiation to 3 or more areas in my mouth.
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I can rinse my mouth with the study medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am younger than 18 years old.
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I am using topical corticosteroids in my mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,132 Total Patients Enrolled
9 Trials studying Oral Complications
1,005 Patients Enrolled for Oral Complications
Guy J. F. Juillard, MDStudy ChairJonsson Comprehensive Cancer Center

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT00022373 — Phase 3
Oral Complications Research Study Groups:
Oral Complications Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT00022373 — Phase 3
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00022373 — Phase 3
~14 spots leftby Dec 2025
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