Clinical trial · Interventional
The Effect of Sodium Thiosulfate Eardrops on Hearing Loss in Patients Who Receive Cisplatin Therapy
A Pilot, Randomized, Self-controlled Study of the Effects of Intratympanic Sodium Thiosulfate on the Degree of Hearing Loss in Patients Receiving Cisplatin Therapy
- 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 is a pilot, randomized, self-controlled study of the effects of intratympanic sodium thiosulfate (STS) on the degree of hearing loss in patients receiving cisplatin therapy. Sodium thiosulfate is an inactive ingredient contained in sulfacetamide ophthalmic solution which is used routinely as an otic solution delivered to the middle ear space. The hypothesis of this study is that local administration of sodium thiosulfate (STS) will result in improved hearing compared to ears not receiving the study drug in patients receiving systemic cisplatin therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Insertion of Pressure Equalization (PE) Tubes | Procedure | — | UNRESOLVED |
| Saline (Placebo) | Other | — | UNRESOLVED |
| Sodium Thiosulfate (STS) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Ear - Sodium Thiosulfate (STS)
- description
- Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.
- interventionNames
- Procedure: Insertion of Pressure Equalization (PE) Tubes
- Drug: Sodium Thiosulfate (STS)
- Drug: Cisplatin
- type
- PLACEBO_COMPARATOR
- label
- Comparator Ear - Placebo
- description
- Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.
- interventionNames
- Procedure: Insertion of Pressure Equalization (PE) Tubes
- Other: Saline (Placebo)
- Drug: Cisplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults receiving cisplatin therapy in the dose range of 80-120mg/m2 2. Subjects are capable of giving informed consent, or if appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf. Exclusion Criteria: 1. Subjects with active middle ear disease (unilateral or bilateral) 2. Subjects with prior treatment with platinum-based chemotherapeutic agent or other ototoxic agent 3. Subjects with an allergy to sodium thiosulfate 4. Subjects with tumors involving cranial nerve VIII 5. Subjects with preexisting absence of otoacoustic emissions (unilateral or bilateral) 6. Subjects with more than 5 dB interaural difference in puretone threshold on initial audiometric screening 7. Chronic use of known ototoxic agent (e.g. furosemide, aminoglycosides, etc) 8. Subjects with a history of prior irradiation to the head and neck.
References
Publications (0)
Data not yet available