Sodium Thiosulfate + Mannitol: Drug delivery will be sequential, where Mannitol will be infused over 30 minutes and Sodium Thiosulfate will be infused over 15 minutes.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
* Any patient who is of reproductive age should provide written agreement to use adequate contraception for the duration of the trial
Exclusion Criteria:
* 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
* Abnormal renal function (creatinine clearance \<60 ml/min)
* Abnormal liver function (liver function tests (ALT and ALP) \>2.5 times upper limit of normal without liver metastasis and \>5 times upper limit of normal with liver metastasis
* Previous hypersensitivity to STS or mannitol
* Pregnant and/or nursing women
* Patient unable to follow the protocol for any reason
Primary outcome measure(s)
Improvement in hearing threshold with sodium thiosulfate and mannitol administration — 2 months 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.
Trial sites (1)
Facility
City
Region
Status
Sunnybrook Health Sciences Centre
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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