Cancer Clinical Trial
Official title:
A Pilot, Randomized, Self-controlled Study of the Effects of Intratympanic Sodium Thiosulfate on the Degree of Hearing Loss in Patients Receiving Cisplatin Therapy
Verified date | September 2017 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | May 2, 2013 |
Est. primary completion date | March 10, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adults receiving cisplatin therapy in the dose range of 80-120mg/m2 2. 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: 1. Subjects with active middle ear disease (unilateral or bilateral) 2. Subjects with prior treatment with platinum-based chemotherapeutic agent or other ototoxic agent 3. Subjects with an allergy to sodium thiosulfate 4. Subjects with tumors involving cranial nerve VIII 5. Subjects with preexisting absence of otoacoustic emissions (unilateral or bilateral) 6. Subjects with more than 5 dB interaural difference in puretone threshold on initial audiometric screening 7. Chronic use of known ototoxic agent (e.g. furosemide, aminoglycosides, etc) 8. Subjects with a history of prior irradiation to the head and neck. |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of Intratympanic Sodium Thiosulfate (STS) | To assess the efficacy of intratympanic sodium thiosulfate (STS) on reducing the degree or incidence of hearing loss in patients receiving systemic cisplatin therapy using puretone and speech audiometry, and distortion product otoacoustic emissions (DPOAE). Pure tone and speech audiometry: hearing will be assessed prior to any initiation of cisplatin therapy, again at three weeks, 6 weeks, 12 weeks, and every 6 months thereafter for up to one year. |
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