N-Acetylcysteine for Chemotherapy-Induced Hearing Loss

Recruiting in Palo Alto (17 mi)

Overseen byTrung N Le

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?Although many intratympanic agents have been attempted, N-Acetylcysteine (NAC) appears to be the most promising and is a powerful, commonly used anti-oxidant. The goal of this prospective phase 2 randomized controlled trial is to determine the optimal dosage and effectiveness of intratympanic NAC injection in reducing hearing loss in head \& neck cancer patients receiving cisplatin chemotherapy with curative intent.

Eligibility Criteria

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.

Inclusion Criteria

My condition is advanced head and neck cancer.

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

Willing to provide informed consent

+2 more

Exclusion Criteria

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

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

Your ears have a difference in hearing of more than 10 decibels at three different pitches before treatment.

+5 more

Participant Groups

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.

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