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The Effect of Sodium Thiosulfate Eardrops on Hearing Loss in Patients Who Receive Cisplatin Therapy

NCT01369641 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-05-16

Study results available
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Summary

This is a pilot, randomized, self-controlled study of the effects of intratympanic sodium thiosulfate (STS) on the degree of hearing loss in patients receiving cisplatin therapy. Sodium thiosulfate is an inactive ingredient contained in sulfacetamide ophthalmic solution which is used routinely as an otic solution delivered to the middle ear space.

The hypothesis of this study is that local administration of sodium thiosulfate (STS) will result in improved hearing compared to ears not receiving the study drug in patients receiving systemic cisplatin therapy.

Conditions

Interventions

PROCEDURE

Insertion of Pressure Equalization (PE) Tubes

If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.

DRUG

Sodium Thiosulfate (STS)

Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.

OTHER

Saline (Placebo)

Drops of balanced saline solution will be added to the placebo comparator ear prior to initial cisplatin infusion.

DRUG

Cisplatin

Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2

Sponsors & Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • David Cognetti, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-24
Primary Completion
2013-03-10
Completion
2013-05-02

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01369641 on ClinicalTrials.gov