Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
A Multicenter Randomized Phase II Clinical Trial of the Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
Sunnybrook Health Sciences Centre
92 participants
Feb 15, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria9
- 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
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Interventions
Drug delivery will be sequential, where Mannitol will be infused over 30 minutes and Sodium Thiosulfate will be infused over 15 minutes.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05129748