The Effect of Sodium Thiosulfate Eardrops on Hearing Loss in Patients Who Receive Cisplatin Therapy (NCT01369641) | Clinical Trial Compass
TerminatedNot Applicable
The Effect of Sodium Thiosulfate Eardrops on Hearing Loss in Patients Who Receive Cisplatin Therapy
Stopped: Poor accrual
United States1 participantsStarted 2011-08-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults receiving cisplatin therapy in the dose range of 80-120mg/m2
✓. Subjects are capable of giving informed consent, or if appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf.
Exclusion criteria
✕. Subjects with active middle ear disease (unilateral or bilateral)
✕. Subjects with prior treatment with platinum-based chemotherapeutic agent or other ototoxic agent
✕. Subjects with an allergy to sodium thiosulfate
✕. Subjects with tumors involving cranial nerve VIII
✕. Subjects with preexisting absence of otoacoustic emissions (unilateral or bilateral)
✕. Subjects with more than 5 dB interaural difference in puretone threshold on initial audiometric screening
✕. Chronic use of known ototoxic agent (e.g. furosemide, aminoglycosides, etc)
What they're measuring
1
Efficacy of Intratympanic Sodium Thiosulfate (STS)
Timeframe: Through 1 year post-treatment
Trial details
NCT IDNCT01369641
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University