IRB Study Number 25-078
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objectives
To test the feasibility of a consistent ototoxicity screening protocol
To assess whether hearing loss has an impact on participants’ quality of life before,
during, and after cisplatin treatment.
Secondary Objectives
To assess the incidence, degree, and timing of hearing loss
To describe participants’ perception of hearing loss
Inclusion Criteria
Patients aged 18 and above
Patients diagnosed with a squamous cell carcinoma of the head and neck
Patients planning to undergo chemotherapy utilizing cisplatin
Life expectancy of at least 6-months
Willing and able to provide informed consent, participate in study required hearing tests with headphones, and survey completion
Exclusion Criteria
- Patients with existing hearing loss defined as:
a. Use of hearing aids at the time of initiation of cisplatin treatment
b. Participants discovered to have clinically significant hearing loss during study screening (moderate to severe hearing loss which requires amplification at 60 dB across any tested frequency as determined by the initial audiogram with audiology)
c. Patients self-identifying as having hearing loss but do not use hearing aids
Patients currently taking an ototoxic medication
Patients with a form of cancer other than, or in addition to, head and neck cancer
Patients for whom participating in the study, in the opinion of the investigator, would be unduly burdensome, confounding to study results, medically contra-indicated or not in the patient’s best interests.
Patients who had previously been treated with platinum-based chemotherapy or had taken aminoglycoside based antibiotics
