Actively Recruiting
A Multicenter Randomized Phase II Trial of Sodium Thiosulfate and Mannitol to Reduce Hearing Loss in Adults Receiving Cisplatin Chemotherapy
Led by Sunnybrook Health Sciences Centre · Updated on 2023-04-14
92
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of sodium thiosulfate and mannitol on preventing hearing loss caused by cisplatin chemotherapy in adult cancer patients. This phase II randomized trial aims to evaluate if these drugs can protect the inner ear cells and reduce ototoxicity, which is a common side effect of cisplatin treatment. The study includes a pilot phase to assess feasibility, safety, and treatment outcomes. Participants are randomly assigned to one of two groups: one receiving standard cisplatin chemotherapy alone, and the other receiving cisplatin chemotherapy followed by intravenous sodium thiosulfate and mannitol 4 to 8 hours later. Mannitol is infused over 30 minutes, then sodium thiosulfate over 15 minutes, as part of post-chemotherapy hydration. The pilot study involves 24 patients over two years, with plans to expand based on initial results. Before treatment, participants undergo hearing tests to establish baseline hearing levels. Follow-up hearing assessments are done at specific intervals after completing cancer therapy to measure changes in hearing thresholds. Researchers will also monitor kidney and liver function, survival outcomes, and report any adverse effects over a 12-month period. The total study duration and ongoing monitoring aim to ensure safety and evaluate the long-term impact of the intervention.
CONDITIONS
Brief 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 undergoing systemic cisplatin chemotherapy for cancer treatment
- Age 18 years or older
- Willing to provide informed consent
- ECOG performance status between 0 and 2
- Negative pregnancy test for females of childbearing potential before study treatment
- Agreement to use effective contraception if of reproductive age during the trial
You will not qualify if you...
- Age under 18 years
- Severe to profound sensorineural hearing loss in one or both ears confirmed by audiogram
- History of Meniere's disease or fluctuating hearing loss
- Asymmetrical hearing loss based on specific audiogram thresholds
- Abnormal kidney function with creatinine clearance less than 60 ml/min
- Abnormal liver function with elevated liver tests beyond specified limits
- Previous allergic reaction to sodium thiosulfate or mannitol
- Pregnant or nursing women
- Inability to follow the study protocol for any reason
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of chemotherapy treatment cycles
Participants receive cisplatin chemotherapy. Those in the experimental group will also receive sodium thiosulfate and mannitol intravenously 4 to 8 hours after chemotherapy as part of post-chemotherapy hydration.
Visits for each chemotherapy cycle including infusion of sodium thiosulfate and mannitol in the experimental group
Duration - Up to 12 months
Participants undergo follow-up hearing tests and monitoring for potential oncological impacts and adverse events after completion of cancer treatment.
Follow-up visits at select time intervals over 12 months
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Actively Recruiting
Research Team
Y
Yasmeen Aboulhawa
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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