Recruiting
Phase 2

Sodium Thiosulfate & Mannitol

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05129748

Conditions

Ototoxic Hearing Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sodium Thiosulfate + Mannitol

Study Details

Brief 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.

Conditions

Ototoxic Hearing Loss

Study ID

NCT05129748

Start date

Feb 15, 2023

Status verified date

Apr, 2023

Completion date

Dec, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Standard Cisplatin-based Chemotherapy + Sodium Thiosulfate + Mannitol

Participants will receive the standard of care (cisplatin-based chemotherapy) plus the experimental treatment of Sodium Thiosulfate and Mannitol. Both drugs will be administered IV 4 - 8 hours following chemotherapy treatment, as part of post-chemotherapy hydration.

no intervention: Standard Cisplatin-based Chemotherapy

Participants will receive the standard of care (cisplatin-based chemotherapy) only.

Interventions

Sodium Thiosulfate + Mannitol

Drug delivery will be sequential, where Mannitol will be infused over 30 minutes and Sodium Thiosulfate will be infused over 15 minutes.

Primary outcome measure

  • Improvement in hearing threshold with sodium thiosulfate and mannitol administration [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Yasmeen Aboulhawa

1-416-480-6100yasmeen.aboulhawa@sri.utoronto.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

Contacts

Yasmeen Aboulhawa

yasmeen.aboulhawa@sri.utoronto.ca

Principal Investigator:

Trung Le

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 14, 2023

Last verified

Apr, 2023

Keywords

  • Hearing Loss
  • Deafness
  • Cisplatin-induced Ototoxicity
  • Sensorineural hearing loss
  • Ear diseases
  • Sodium Thiosulfate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-04-14.