Clinical trial · Interventional
Efficacy of Trans-tympanic Injections of a Sodium Thiosulfate Gel to Prevent Cisplatin-induced Ototoxicity
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Effect | — | UNRESOLVED | — |
| DDP | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trans-tympanic injection of a sodium thiosulfate gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treated ear
- description
- Trans-tympanic injection of a sodium thiosulfate gel
- interventionNames
- Drug: Trans-tympanic injection of a sodium thiosulfate gel
- type
- NO_INTERVENTION
- label
- Control ear
- description
- No intervention
Primary outcomes (1)
- measure
- Hearing loss at high frequencies
- timeFrame
- One month after Cisplatin treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available