NCT05129748 Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
| NCT ID | NCT05129748 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Ototoxic Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2023-02-15 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 92 participants in total. It began in 2023-02-15 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05129748 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ototoxic Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05129748 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05129748 currently recruiting?
Yes, NCT05129748 is actively recruiting participants. Contact the research team at yasmeen.aboulhawa@sri.utoronto.ca for enrollment information.
Where is the NCT05129748 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05129748 clinical trial?
NCT05129748 is sponsored by Sunnybrook Health Sciences Centre. The trial plans to enroll 92 participants.