Who is eligible for clinical trial NCT05129748?

Participants must meet protocol criteria for Ototoxic Hearing Loss. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05129748 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2023-04-12

Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy (NCT05129748)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sunnybrook Health Sciences Centre

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (10 items).

Location: Sunnybrook Health Sciences Centre — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Sunnybrook Health Sciences Centre — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗