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Tests treatment safety and results for Ototoxic Hearing Loss
Official title Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
ClinicalTrials.gov ID: NCT05129748
What this study is testing
What is Sodium Thiosulfate + Mannitol?
Sodium Thiosulfate + Mannitol is an investigational medicine, being studied as a potential treatment for ototoxic hearing loss.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- One common side effect of cisplatin chemotherapy is ototoxicity. The drugs sodium thiosulfate and mannitol may protect against cisplatin-induced hearing loss.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Age less than 18
- Preexisting severe to profound sensorineural hearing loss (unilateral or bilateral) (speech reception threshold \>70dB, or word recognition score...
- 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...
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.