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

NCT01369641 | Terminated Results DMC

• 3 other identifiers: 11D.992011-03JT 2092
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

cisplatin; STS; sodium thiosulfate; Adults; dose range of 80-120mg/m2

Outcome Measures

Primary Outcomes (1)

• 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.

  Through 1 year post-treatment

Study Arms (2)

Experimental Ear - Sodium Thiosulfate (STS)

EXPERIMENTAL

Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.

Procedure: Insertion of Pressure Equalization (PE) Tubes; Drug: Sodium Thiosulfate (STS); Drug: Cisplatin

Comparator Ear - Placebo

PLACEBO COMPARATOR

Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.

Procedure: Insertion of Pressure Equalization (PE) Tubes; Other: Saline (Placebo); Drug: Cisplatin

Interventions

Insertion of Pressure Equalization (PE) Tubes PROCEDURE

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.

Also known as: PE, tympanostomy tubes, myringotomy tubes

Comparator Ear - Placebo; Experimental Ear - Sodium Thiosulfate (STS)

Sodium Thiosulfate (STS) DRUG

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

Also known as: sodium thiosulphate

Experimental Ear - Sodium Thiosulfate (STS)

Saline (Placebo) OTHER

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

Also known as: saline solution

Comparator Ear - Placebo

Cisplatin DRUG

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

Also known as: cisplatinum, cis-diamminedichloroplatinum(II), CDDP, Platinol, Platinol-AQ

Comparator Ear - Placebo; Experimental Ear - Sodium Thiosulfate (STS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Subjects with a history of prior irradiation to the head and neck.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Neoplasms

Interventions

sodium thiosulfate; Sodium Chloride; Saline Solution; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

Study terminated due to poor accrual, prior to subjects being analyzed.

Results Point of Contact

• Title: David Cognetti, MD
• Organization: Thomas Jefferson University

David.Cognetti@jefferson.edu

215-955-6670

Study Officials

• David Cognetti, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 9, 2011
• Study Start: August 24, 2011
• Primary Completion: March 10, 2013
• Study Completion: May 2, 2013
• Last Updated: May 16, 2025
• Results First Posted: May 1, 2014

Record last verified: 2025-05

Locations

US (1)