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

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Nov 18, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether two medications, sodium thiosulfate and mannitol, can help protect against hearing loss caused by cisplatin chemotherapy, which is often used to treat cancer. Ototoxicity, or hearing loss due to medication, is a common concern for patients receiving this type of treatment. Sodium thiosulfate is believed to help protect the inner ear cells, while mannitol may help deliver sodium thiosulfate more effectively to those cells. The goal of the study is to see if these medications can reduce the risk of hearing impairment for adults undergoing cisplatin therapy.

To participate in this trial, you must be at least 18 years old and currently receiving cisplatin as part of your cancer treatment. You also need to be in good health overall, meaning you can perform daily activities with minimal assistance. Women of childbearing age will need to take a pregnancy test and agree to use birth control during the study. Participants will be closely monitored throughout the trial to assess how well the medications are working and to ensure their safety. If you're considering joining, it's important to discuss this trial with your healthcare provider to see if it might be right for you.

Gender

ALL

Eligibility criteria

• Inclusion 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
• 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