Randomized Phase II Trial to Test Sodium Thiosulfate and Mannitol in Protecting Against Hearing Loss from Cisplatin Chemotherapy in Adults

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.

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