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

• Status: Terminated
• Trial end date: 2013-05-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Treatments: Cisplatin; Sodium thiosulfate

Criteria

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.