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Sodium Thiosulfate + Mannitol for Chemotherapy-Induced Hearing Loss

Phase 2

Recruiting

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undertaking systemic cisplatin therapy as part of their cancer treatment

ECOG performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial looks at if sodium thiosulfate and mannitol can help protect against hearing loss caused by cisplatin chemotherapy.

Who is the study for?

Adults over 18 receiving cisplatin chemotherapy can join this trial if they're willing to consent and use contraception. They must have normal hearing, good overall health (ECOG 0-2), and proper kidney and liver function. Pregnant women or those with severe hearing loss, Meniere's disease, fluctuating or asymmetrical hearing loss are excluded.Check my eligibility

What is being tested?

The trial is testing whether Sodium Thiosulfate plus Mannitol can prevent hearing damage in adults undergoing cisplatin chemotherapy. The study will assess the effectiveness of these drugs in protecting inner ear cells from the ototoxic effects of chemotherapy.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to Sodium Thiosulfate or Mannitol. Since these drugs aim to protect against hearing loss, there might be fewer ear-related issues compared to taking cisplatin alone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently receiving cisplatin as part of my cancer treatment.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement in hearing threshold with sodium thiosulfate and mannitol administration

Secondary outcome measures

To assess the short and long-term adverse event reporting from combination of sodium thiosulfate, mannitol and cisplatin.

To monitor potential oncological impact of sodium thiosulfate and mannitol on disease free survival

To monitor potential oncological impact of sodium thiosulfate and mannitol on long-term renal clearance

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard Cisplatin-based Chemotherapy + Sodium Thiosulfate + MannitolExperimental Treatment1 Intervention

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.

Group II: Standard Cisplatin-based ChemotherapyActive Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,585 Total Patients Enrolled

1 Trials studying Ototoxic Hearing Loss

80 Patients Enrolled for Ototoxic Hearing Loss

Media Library

Standard Cisplatin-based Chemotherapy + Sodium Thiosulfate + Mannitol Clinical Trial Eligibility Overview. Trial Name: NCT05129748 — Phase 2

Ototoxic Hearing Loss Research Study Groups: Standard Cisplatin-based Chemotherapy + Sodium Thiosulfate + Mannitol, Standard Cisplatin-based Chemotherapy

Ototoxic Hearing Loss Clinical Trial 2023: Standard Cisplatin-based Chemotherapy + Sodium Thiosulfate + Mannitol Highlights & Side Effects. Trial Name: NCT05129748 — Phase 2

Standard Cisplatin-based Chemotherapy + Sodium Thiosulfate + Mannitol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05129748 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial currently enrolling participants?

"Clinicaltrials.gov reveals that this investigation, which was first posted on February 15th 2023 is actively seeking participants. The information has been most recently updated on April 12th 2023."

Answered by AI

What is the aggregate count of participants in this research study?

"Affirmative. Clinicaltrials.gov records show that this trial initiated on February 15th 2023 and was recently updated in April of the same year. 92 participants are needed to be recruited from just one medical center."

Answered by AI

Are there any studies that have examined the effects of Standard Cisplatin-based Chemotherapy, Sodium Thiosulfate and Mannitol in tandem?

"Currently, 20 trials are running which examine Standard Cisplatin-based Chemotherapy + Sodium Thiosulfate + Mannitol. Of those studies 7 have advanced to Phase 3 testing. Most of these clinical investigations take place in Tauranga, New South Wales; yet there are 86 other locations that host related research initiatives."

Answered by AI

What medical maladies can be treated by Standard Cisplatin-based Chemotherapy + Sodium Thiosulfate + Mannitol?

"Sodium Thiosulfate, Mannitol and Standard Cisplatin-based Chemotherapy are regularly administered to treat glucose tolerance tests. Additionally, they can be applied to manage glomerular filtration rate measurement, renal insufficiency, acute state and transurethral surgery."

Answered by AI

Could you describe the potential hazards of combining Standard Cisplatin-based Chemotherapy, Sodium Thiosulfate and Mannitol?

"Despite having limited clinical evidence in support of efficacy, the safety rating given to Standard Cisplatin-based Chemotherapy + Sodium Thiosulfate + Mannitol is 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05129748.

All > Toxicity > Hearing Loss