Head and Neck Cancer Clinical Trial
— STS001Official title:
Randomized Controlled Trial to Test the Efficacy of Trans-tympanic Injections of a Sodium Thiosulfate Gel to Prevent Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer
Verified date | January 2017 |
Source | Centre Hospitalier Universitaire de Québec, CHU de Québec |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates whether a gel containing sodium thiosulfate deposited via a trans-tympanic injection on the round window of the middle ear could reduce the ototoxicity caused by the drug Cisplatin among patients with head and neck cancer treated by chemoradiation. One ear selected randomly will be treated while the other will serve as control.
Status | Terminated |
Enrollment | 13 |
Est. completion date | January 20, 2017 |
Est. primary completion date | January 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with newly diagnosed locally advanced (stage III or IV) squamous cell carcinoma of the mouth, oropharynx, hypopharynx, or larynx scheduled to be treated with concomitant chemoradiation including Cisplatin100 mg/m2 3 times - Normal otoscopic findings and symmetrical hearing Exclusion Criteria: - Karnofsky below 70 |
Country | Name | City | State |
---|---|---|---|
Canada | CHU de Quebec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Québec, CHU de Québec |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hearing loss at high frequencies | Hearing loss defined by the difference between the average permanent threshold shift (PTS) in dB (decibel) at four pure tone high frequencies (9, 10, 12.5 and 14 kHz) using the data from the audiograms done before and one month after Cisplatin therapy, for each patient and for each ear. | One month after Cisplatin treatment | |
Secondary | Cochlear damage | Cochlear damage defined by the difference between the distortion product otoacoustic emissions (DPOAEs) recording before and one month after Cisplatin therapy, for each patient and for each ear. | One month after Cisplatin treatment | |
Secondary | Hearing loss at lower frequencies | Hearing loss defined by the difference between the average permanent threshold shift (PTS) in dB (decibel) at four pure tone frequencies (0.5 to 8 kHz) using the data from the audiograms done before and one month and one year after Cisplatin therapy, for each patient and for each ear. | One month and one year after Cisplatin treatment | |
Secondary | Adverse effects of trans-tympanic injections | Ototoxicity severity according to CTCAE after each trans-tympanic injection | One month after Cisplatin treatment |
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