NCT04291209

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2020

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

4.2 years

First QC Date

February 26, 2020

Last Update Submit

September 5, 2023

Conditions

Ototoxic Hearing Loss

Keywords

Hearing LossDeafnessCisplatin-induced OtotoxicitySensorineural hearing lossEar diseasesAntioxidantN-acetyl cystein

Outcome Measures

Primary Outcomes (2)

  • Determination of a safe and tolerable dosage for intratympanic NAC injection

    The primary end-point of the phase 1 part of this study is the safety and tolerability of intratympanic NAC injections, by determining the causality of adverse events and serious adverse events and grading according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v.5.0

    Within 1 day

  • Improvement in hearing threshold with intratympanic NAC injection

    The primary outcome measure of this study will be a comparison of hearing loss between the control and NAC-injected ears. More specifically, each ear will be scored as having hearing loss if there is a greater than 10dB hearing loss in three contiguous frequencies. This will be measured via threshold hearing tests.

    Within 2 months

Secondary Outcomes (1)

  • Improvement in hearing quality with intratympanic NAC injection

    Within 2 months

Study Arms (2)

Experimental arm with Intratympanic NAC injection

ACTIVE COMPARATOR

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

Drug: N-Acetyl Cysteine

Control arm with No injection

NO INTERVENTION

The control ear will not receive any injections

Interventions

N-Acetyl CysteineDRUG

One ear will be randomly chosen for the experimental treatment of intratympanic NAC. The other ear will serve as the control ear which will not receive any injection.

Also known as: NAC
Experimental arm with Intratympanic NAC injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced stage head and neck cancer
  • Receiving high dose systemic cisplatin (100mg/m2) with concurrent radiation therapy as part of their curative intent treatment
  • Willing to provide informed consent
  • ECOG performance status 0-2
  • Histological confirmation of squamous cell carcinoma

You may not qualify if:

  • Age less than 18
  • Metastatic disease
  • Tympanic membrane perforation or the presence of tympanostomy tubes as this may impact the retention and absorption of NAC when inserted into the middle ear
  • Preexisting severe to profound sensorineural hearing loss (unilateral or bilateral)
  • Pretreatment interaural discrepancy of greater than 10dB at three frequencies
  • History of Meniere's or fluctuating hearing loss
  • Previous hypersensitivity to NAC
  • Patient unable to follow the protocol for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Hearing LossDeafnessHearing Loss, SensorineuralEar Diseases

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Hearing DisordersOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Trung N Le

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Varia Sajeniouk

CONTACT

1-416-480-6100varia.sajeniouk@sunnybrook.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trung N. Le MD PhD

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 2, 2020

Study Start

February 26, 2020

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)