Actively Recruiting
Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
Led by Sunnybrook Health Sciences Centre · Updated on 2023-04-14
92
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undertaking systemic cisplatin therapy as part of their cancer treatment
- Age 218
- Willing to provide informed consent
- ECOG performance status 0-2
- For females of child-bearing potential, a negative pregnancy test (beta-HCG) prior to study treatment is required
- Patients of reproductive age must agree in writing to use effective contraception during the trial
You will not qualify if you...
- Age less than 18
- Preexisting severe to profound sensorineural hearing loss (speech reception threshold >70dB, or word recognition score <50%) confirmed by audiogram
- History of Meniere's disease or fluctuating hearing loss
- Asymmetrical hearing loss with specific bone conduction threshold differences
- Abnormal kidney function (creatinine clearance <60 ml/min)
- Abnormal liver function tests (ALT and ALP >2.5 times upper limit without liver metastasis; >5 times with metastasis)
- Previous hypersensitivity to sodium thiosulfate or mannitol
- Pregnant or nursing women
- Inability to follow the study protocol for any reason
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Actively Recruiting
Research Team
Y
Yasmeen Aboulhawa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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