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

This study has been terminated.
(Poor accrual)
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01369641
First received: June 7, 2011
Last updated: March 28, 2014
Last verified: March 2014
Results First Received: January 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Cancer
Interventions: Procedure: Insertion of Pressure Equalization (PE) Tubes
Drug: Sodium Thiosulfate (STS)
Other: Saline (Placebo)
Drug: Cisplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sodium Thiosulfate (STS) Ear & Placebo Ear

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.

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.

Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.

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


Participant Flow:   Overall Study
    Sodium Thiosulfate (STS) Ear & Placebo Ear  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sodium Thiosulfate (STS) Ear & Placebo Ear

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.

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.

Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.

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


Baseline Measures
    Sodium Thiosulfate (STS) Ear & Placebo Ear  
Number of Participants  
[units: participants]
  1  
Age  
[units: years]
Mean ± Standard Deviation
  69.26  ± 0  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     1  
Gender  
[units: participants]
 
Female     0  
Male     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     1  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     1  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures

1.  Primary:   Efficacy of Intratympanic Sodium Thiosulfate (STS)   [ Time Frame: Through 1 year post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated due to poor accrual, prior to subjects being analyzed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Cognetti, MD
Organization: Thomas Jefferson University
phone: 215-955-6670
e-mail: David.Cognetti@jefferson.edu


No publications provided


Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01369641     History of Changes
Other Study ID Numbers: 11D.99, 2011-03
Study First Received: June 7, 2011
Results First Received: January 24, 2014
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board