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

Phase

Condition

Hearing Impairment

Auditory Loss And Deafness

Hearing Loss

Treatment

N/A

Clinical Study ID

NCT05129748

1818

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 tostudy treatment is required
Any patient who is of reproductive age should provide written agreement to useadequate contraception for the duration of the trial

Exclusion

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 withan audiogram
History of Meniere's or fluctuating hearing loss
Asymmetrical hearing loss (bone conduction threshold difference of: (a) 20 dBthreshold difference at a single frequency, (b) 15 dB threshold difference at 2frequencies, (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 ofnormal without liver metastasis and >5 times upper limit of normal with livermetastasis
Previous hypersensitivity to STS or mannitol
Pregnant and/or nursing women
Patient unable to follow the protocol for any reason

Study Design

February 15, 2023

December 31, 2027

Study Description

Randomized phase II clinical trial: with 1:1 randomization between cisplatin alone, and cisplatin + sodium thiosulfate and mannitol. Participants will first be recruited into a 2-year pilot feasibility study of 24 patients (12 in each arm). The pilot study will be performed to evaluate the feasibility of the trial as defined by the following factors: treatment outcomes, occurrence of adverse events, logistics of treatment delivery, as well as dropout and recruitment rates. The results from the pilot study will support the safety, efficacy, and effectiveness of the sodium thiosuldate and mannitol treatment, confirm feasibility using the factors mentioned above, and serve as an earlier-phase developmental function to enhance the probability of success of the subsequent clinical trial. Participants will complete various pre-treatment hearing tests. Participants will receive sodium thiosulfate and mannitol 4 - 8 hours following chemotherapy treatment. The control group will not receive the experimental intervention. Follow-up hearing tests will be performed at select time intervals following completion of their cancer treatment.

Connect with a study center

Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada
Active - Recruiting

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