Efficacy of intratympanic sodium thiosulfate gel injection to preventisplatin-induced ototoxicity: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240520004

Enrollment

Registered

2024-05-20

Start date

2024-05-20

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cisplatin-induced ototoxicity Cisplatin Sensorineural hearing loss Sodium thiosulfate

Interventions

Before the intratympanic injection, 1% xylocaine soaked gauze as a local anesthesia will be placed closed to the tympanic membrane of the intervention ear for 15 minutes then removed. The patient will

Experimental Drug,No Intervention No treatment

Intratympanic sodium thiosulfate injection (Intervention ear),No treatment (Control ear)

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 20 years and above 2. Head and neck cancer patients with confirmed histology 3. Plan to receive high dose cisplatin (> 100 mg mg/m2/cycle) treatment as adjuvant, neoadjuvant or palliative chemotherapy

Exclusion criteria

Exclusion criteria: 1. Nasopharyngeal cancer and others cancer which mass obstructing eustachian tube 2. History of ear disease, head trauma or prior ear surgery 3. Abnormal tympanic membrane or narrow ear canal of any ear 4. Asymmetrical hearing at baseline (definition is the asymmetry between two ears of more than 10 dB at any frequency) 5. Hearing loss at baseline PTA > 55 dB (Moderately severe sensorineural hearing loss) 6. History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) to the excipients of the study medications (STS, hyaluronic acid)

Design outcomes

Primary

Measure	Time frame
Hearing thresholds (decibels) baseline, before each dose of cisplatin (interval 3 weeks for 3 cycles), 1 and 3 months after completion of chemotherapy Standard audiometry for hearing test in a sound proof room	—

Secondary

Measure	Time frame
Adverse effects of intratympanic STS injection baseline, before each dose of cisplatin (interval 3 weeks for 3 cycles), 1 and 3 months after completion of chemotherapy Case record form: Symptoms (hearing loss, tinnitus, vertigo, dizziness) and Physical examination (tympanic membrane perforation)	—

Countries

Thailand

Contacts

Public ContactPattarawadee Prayuenyong

Faculty of Medicine, Prince of Songkla University

fernny_patt@hotmail.com074451390

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026