Head and Neck squamous cell carcinoma
Conditions
Brief summary
The percent of patients with a clinically relevant benefit of transtympanic STS injection against CIHL, defined as the change in the threshold between baseline and 3 months after treatment differs by ≥ 10 dB at any three adjacent frequencies from 0.5 to 16 kHz in favour of the STS treated ear.
Detailed description
Mean difference between STS- and untreated ears in threshold shift (post-treatment minus baseline hearing, in a continuous scale) at sensorineural pure tone averages (PTA) 1-2-4 kHz and 8-10-12.5 kHz in dB., The difference in sensorineural hearing loss between STS- and untreated ears based on the ASHA criteria(38): Grade A: threshold shift ≥ 20 dB at any one test frequency; Grade B: threshold shift ≥ 10 dB at 2 consecutive frequencies; Grade C: loss of response at three consecutive test frequencies where responses were previously obtained, The difference in sensorineural hearing loss between STS- and untreated ears based on the TUNE criteria (39) Grade 0: No hearing loss Grade 1a: threshold shift >10dB at PTA 8-10-12.5 kHz OR subjective hearing changes without threshold shift Grade 1b: threshold shift >10dB at PTA 1-2-4 kHz Grade 2a: threshold shift >20dB at PTA 8-10-12.5 kHz Grade 2b: threshold shift >20dB at PTA 1-2-4 kHz Grade 3: Hearing level >35dB HL at PTA 1-2-4 kHz de novo Grade 4: Hearing level >70dB HL at PTA 1-2-4, The difference in sensorineural hearing loss between the STS- and untreated ears based on the CTCAE criteria (40), Disease-specific survival, recurrence-free and overall survival measured at median 1 and 2 years after the start of treatment., 6. Quality of life/Patient-related outcome measures (PROM). Subjective hearing loss after platinum treatment. Measured by two questionnaires: a) Speech, Spatial and Qualities of Hearing scale (SSQ) compare; b) Tinnitus Handicap Inventory (THI)-12.
Interventions
DRUGSODIUM THIOSULFATE
Sponsors
Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent of patients with a clinically relevant benefit of transtympanic STS injection against CIHL, defined as the change in the threshold between baseline and 3 months after treatment differs by ≥ 10 dB at any three adjacent frequencies from 0.5 to 16 kHz in favour of the STS treated ear. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean difference between STS- and untreated ears in threshold shift (post-treatment minus baseline hearing, in a continuous scale) at sensorineural pure tone averages (PTA) 1-2-4 kHz and 8-10-12.5 kHz in dB., The difference in sensorineural hearing loss between STS- and untreated ears based on the ASHA criteria(38): Grade A: threshold shift ≥ 20 dB at any one test frequency; Grade B: threshold shift ≥ 10 dB at 2 consecutive frequencies; Grade C: loss of response at three consecutive test frequencies where responses were previously obtained, The difference in sensorineural hearing loss between STS- and untreated ears based on the TUNE criteria (39) Grade 0: No hearing loss Grade 1a: threshold shift >10dB at PTA 8-10-12.5 kHz OR subjective hearing changes without threshold shift Grade 1b: threshold shift >10dB at PTA 1-2-4 kHz Grade 2a: threshold shift >20dB at PTA 8-10-12.5 kHz Grade 2b: threshold shift >20dB at PTA 1-2-4 kHz Grade 3: Hearing level >35dB HL at PTA 1-2-4 kHz de novo Grade | — |
Countries
Netherlands
Outcome results
None listed