Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
Recruiting
Phase 2
Interventional Study
Ototoxic Hearing Loss
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 92 (estimated)
- Sponsor
- Sunnybrook Health Sciences Centre · Other
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About This Trial
One common side effect of cisplatin chemotherapy is ototoxicity. The drugs sodium thiosulfate and mannitol may protect against cisplatin-induced hearing loss. Specifically, sodium thiosulfate has been found to protect the cells in the inner ear, and may therefore prevent hearing loss. Mannitol can help sodium thiosulfate enter the inner ear, and ponteially increase the effectiveness of sodium thio…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients undertaking systemic cisplatin therapy as part of their cancer treatment
* Age ≥ 18
* Willing to provide informed consent
* ECOG performance status 0-2
* For female of child-bearing potential, a negative pregnancy test (beta-HCG) prior to study treatment is required
*…
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