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N-Acetylcysteine for Chemotherapy-Induced Hearing Loss

Phase 1 & 2

Recruiting

Led By Trung N Le

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Advanced stage head and neck cancer

Receiving high dose systemic cisplatin (100mg/m2) with concurrent radiation therapy as part of their curative intent treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 day

Awards & highlights

Study Summary

This trial is testing a new way to give a powerful antioxidant to help protect hearing in cancer patients getting cisplatin chemotherapy.

Who is the study for?

This trial is for adults with advanced head and neck cancer who are about to receive high-dose cisplatin chemotherapy with radiation. They must be in a condition that allows them to perform daily activities (ECOG 0-2) and have squamous cell carcinoma confirmed by tests. It's not for those under 18, with spread-out cancer, ear drum issues, severe hearing loss already present, Meniere's disease, NAC allergy or any inability to follow the study protocol.Check my eligibility

What is being tested?

The trial is testing how well intratympanic injections of an antioxidant called N-Acetylcysteine (NAC) can prevent hearing damage caused by cisplatin chemotherapy in patients being treated for head & neck cancer. Participants will be randomly assigned different doses of NAC to find the most effective one without causing harm.See study design

What are the potential side effects?

Potential side effects from N-Acetylcysteine may include local irritation where it's injected into the ear and possible allergic reactions if there's sensitivity to the drug. Since it’s administered directly into the middle ear, systemic side effects are less likely compared to oral or IV administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is advanced head and neck cancer.

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I am getting high dose cisplatin with radiation for my cancer treatment.

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My cancer is confirmed as squamous cell carcinoma.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of a safe and tolerable dosage for intratympanic NAC injection

Improvement in hearing threshold with intratympanic NAC injection

Secondary outcome measures

Improvement in hearing quality with intratympanic NAC injection

Trial Design

2Treatment groups

Active Control

Group I: Experimental arm with Intratympanic NAC injectionActive Control1 Intervention

One ear will be randomly chosen for the experimental treatment and receive intratympanic NAC injections 60 minutes prior to their scheduled chemotherapy sessions

Group II: Control arm with No injectionActive Control1 Intervention

The control ear will not receive any injections

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

London Regional Cancer Program, CanadaOTHER

10 Previous Clinical Trials

1,198 Total Patients Enrolled

Toronto Sunnybrook Regional Cancer CentreOTHER

9 Previous Clinical Trials

873 Total Patients Enrolled

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,362 Total Patients Enrolled

1 Trials studying Ototoxic Hearing Loss

92 Patients Enrolled for Ototoxic Hearing Loss

Frequently Asked Questions

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

How many people are chosen to participate in this clinical trial?

"The clinical trial is currently seeking patients, as noted on clinicaltrials.gov. This particular study was posted on February 26th 2020 and updated most recently on October 24th 2022; it is looking for 80 people to participate at a single location."

Answered by AI

Are new patients still being accepted for this research study?

"The correct answer is that this clinical trial is actively recruiting participants, according to the information available on clinicaltrials.gov. This study was originally posted on February 26th, 2020 and was last edited on October 24th, 2022. The goal is to enroll 80 participants across 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intratympanic N-Acetylcysteine for Prevention of Cisplatin-induced Ototoxicity.

Dr. Trung Le 2020. "Intratympanic N-Acetylcysteine for Prevention of Cisplatin-induced Ototoxicity.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04291209.

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