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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,153 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the government's stance on this medication?

"We believe that the safety of this intervention falls on a 3 because it is currently in Phase 3 clinical trials. This means that there is some efficacy data as well as multiple rounds of safety data."

Answered by AI

Are people with the required qualifications currently being enrolled in this trial?

"Unfortunately, this trial is not actively recruiting patients right now. However, the 564 other trials listed on clinicaltrials.gov might be of interest. This particular study was first posted on December 1st 2000 and last updated on October 14th 2014."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2000. "Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00022373.

All > Head And Neck Cancer