Reducing hearing loss from cisplatin chemotherapy using sodium thiosulfate and mannitol
A Multicenter Randomized Phase II Clinical Trial of the Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
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 |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05129748 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving systemic cisplatin therapy for cancer treatment.
Not a fit: Patients with preexisting severe to profound hearing loss or certain ear conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.