Reducing hearing loss from cisplatin chemotherapy using sodium thiosulfate and mannitol
Official title: A Multicenter Randomized Phase II Clinical Trial of the Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
Run by Sunnybrook Health Sciences Centre · NCT05129748 · Data updated 2026-11-12
This study is testing if adding sodium thiosulfate and mannitol to cisplatin chemotherapy can help adults avoid hearing loss caused by the treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | February 15, 2023 |
| Main results expected | January 2027 |
| Study ends | December 2027 |
| Registry record updated | April 14, 2023 |
| Trial ID | NCT05129748 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are receiving systemic cisplatin therapy for cancer treatment.
✕Probably not a fit
Patients with preexisting severe to profound hearing loss or certain ear conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of sodium thiosulfate and mannitol in preventing hearing loss caused by cisplatin chemotherapy in adult patients. It is a randomized phase II trial where participants are assigned to receive either cisplatin alone or cisplatin combined with the experimental drugs. The study includes a pilot feasibility phase with 24 patients to assess treatment outcomes, adverse events, and logistics. Participants will undergo hearing tests before and after treatment to measure the impact of the intervention on hearing impairment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of hearing loss in patients undergoing cisplatin chemotherapy.
How similar studies have gone: While the approach of using sodium thiosulfate for ototoxicity is promising, this specific combination with mannitol is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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 * 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
Where it's running
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Yasmeen Aboulhawa
- Email: yasmeen.aboulhawa@sri.utoronto.ca
- Phone: 1-416-480-6100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.