A Multicenter Randomized Phase II Clinical Trial of the Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
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 thiosulfate. This study aims to assess the efficacy of sodium thiosulfate and mannitol to reduce the hearing impairment caused by cisplatin chemotherapy.
• 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
• Any patient who is of reproductive age should provide written agreement to use adequate contraception for the duration of the trial