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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

Must not have

Preexisting severe to profound sensorineural hearing loss (unilateral or bilateral)

History of Meniere's or fluctuating hearing loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 day

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe to profound hearing loss in one or both ears.

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I have had Meniere's disease or changes in my hearing.

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My cancer has spread to other parts of my body.

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I am under 18 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of a safe and tolerable dosage for intratympanic NAC injection

Improvement in hearing threshold with intratympanic NAC injection

Secondary study objectives

Improvement in hearing quality with intratympanic NAC injection

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met