Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT03225157
Eligibility Criteria:
* INCLUSION CRITERIA:
* Adult patients over the age of 18.
* Patients with squamous cell carcinoma of the upper aerodigestive tract including the larynx, hypopharynx, oropharynx, and oral cavity who undergo treatment with concomitant cisplatin chemotherapy and intensity-modulated radiotherapy (IMRT) with curative intent.
* Patients treated with cisplatin chemoradiation either as primary/definitive or adjuvant (post-surgical) therapy.
* Subjects must be able and willing to self-administer their hearing test via the iPad following a brief tutorial with one-on-one instruction from a member of the study team or medical staff.
* Subjects must have hearing thresholds at or better than 80 dB SPL at 1, 2, and 4 kilohertz (kHz) at the time of their baseline audiogram.
* Subjects must have a Type A tympanogram.
* Subjects must be able to provide their own consent.
EXCLUSION CRITERIA:
* Patients with carcinoma of the nasopharynx or paranasal sinuses, who may have Eustachian tube dysfunction (with resultant conductive hearing loss) related to radiation treatment involving these anatomic subsites.
* Patients with active middle ear disease that is likely to influence the results of audiograms during the study, as determined by an Investigator who is an otolaryngologist. If a potential subject reports active middle ear disease, medical records will be reviewed by a study otolaryngologist to determine whether the patient should be excluded.
* Patients with cochlear implants will be excluded.
* Patients with a history of prior treatment with platinum chemotherapy drugs will be excluded.
* Patients who receive taxanes or other cytotoxic chemotherapy drugs in addition to cisplatin will be excluded. The standard of care is cisplatin as monotherapy for previously untreated HNSCC.
* Staff members of the NIDCD Sections that are headed by the PI and LAI will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03225157
Study Brief:
Protocol Section:
NCT03225157