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
Age less than 18
Preexisting severe to profound sensorineural hearing loss (unilateral or bilateral) (speech reception threshold >70dB, or word recognition score <50%) as confirmed with an audiogram
History of Meniere's or fluctuating hearing loss
Asymmetrical hearing loss (bone conduction threshold difference of: (a) 20 dB threshold difference at a single frequency, (b) 15 dB threshold difference at 2 frequencies, (c) 10 dB threshold difference at 3 frequencies
Parallel
Sodium Thiosulfate + Mannitol
DrugDrug delivery will be sequential, where Mannitol will be infused over 30 minutes and Sodium Thiosulfate will be infused over 15 minutes.
Improvement in hearing threshold with sodium thiosulfate and mannitol administration
The primary outcome measure of this study will be a comparison of hearing loss between the control and experimental groups. More specifically, each ear will be scored as having hearing loss if there is a greater than 10dB hearing loss in three contiguous frequencies. This will be measured via threshold hearing tests.
To monitor potential oncological impact of sodium thiosulfate and mannitol on long-term renal clearance
Participants will be monitored for renal function via serum creatinine (umol/L) and creatinine clearance (ml/min).
To monitor potential oncological impact of sodium thiosulfate and mannitol on disease free survival
Participants will be monitored for disease free survival via cancer staging details and clinical prognosis
To monitor potential oncological impact of sodium thiosulfate and mannitol on overall survival
Participants will be monitored for overall survival via time in months
To assess the short and long-term adverse event reporting from combination of sodium thiosulfate, mannitol and cisplatin.
To determine the causality of adverse events and serious adverse events and grading according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v.5.0
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