- Design
- Single-blinded, split-ear randomised controlled trial
- Population
- 28 adults with head and neck cancer receiving cisplatin, Thailand
- Primary outcome
- Incidence of ototoxicity by ASHA criteria
- Effect
- No difference (P = 0.683); 7–10 dB less shift at 4–11 kHz in treated ears
A single-blinded split-ear randomised trial in Thailand enrolled 28 adults with head and neck cancer having cisplatin. Before each cycle, one ear received intratympanic sodium thiosulfate gel and the other served as control. Hearing was tested before each injection and one to three months after chemotherapy.
By standard ASHA criteria across 0.25–8 kHz, ototoxicity incidence did not differ between treated and control ears (P = 0.683). Treated ears did show smaller threshold shifts at 4, 6, 8, 9 and 11 kHz, by about 7–10 dB. Across 74 injections, otalgia and transient vertigo each occurred in about 11%, dizziness in 15% and tympanic membrane perforation in 4%.
Systemic sodium thiosulfate is used in some children to protect hearing, but systemic use in adults raises concern about blunting cisplatin's effect. Local delivery avoids that, but this small trial shows only a partial, high-frequency signal. Baseline and serial audiometry remain the practical step for every patient on cisplatin.
- Arrange baseline audiometry, including high frequencies, before cisplatin starts
- Repeat audiometry during treatment and report changes to the oncology team
- Ask about tinnitus and hearing at every cycle
- Intratympanic thiosulfate remains investigational; consider it only within a trial or protocol
Why it matters
A local ear protector that does not interfere with cisplatin would fill a real gap if larger trials confirm it.
Don't overread it
The primary outcome was negative; the high-frequency benefit is a secondary finding in 28 patients.
The statistics, in plain English
A split-ear design compares each patient's two ears, which controls for individual differences but uses only 28 people. The primary outcome was negative; the high-frequency differences of 7–10 dB were secondary and may matter for speech in noise, but are not proof of benefit.
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