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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

Must not have

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

Preexisting severe to profound sensorineural hearing loss (unilateral or bilateral) (speech reception threshold >70dB, or word recognition score <50%) as confirmed with an audiogram

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver tests are much higher than normal, indicating liver issues.

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I have severe hearing loss confirmed by a hearing test.

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I am under 18 years old.

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I have uneven hearing loss in my ears.

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My kidney function is reduced (creatinine clearance <60 ml/min).

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I have had Meniere's disease or my hearing often changes.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in hearing threshold with sodium thiosulfate and mannitol administration

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met