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Efficacy of Trans-tympanic Injections of a Sodium Thiosulfate Gel to Prevent Cisplatin-induced Ototoxicity (STS001)

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ClinicalTrials.gov Identifier: NCT02281006
Recruitment Status : Terminated (poor accrual)
First Posted : November 3, 2014
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
François Meyer, CHU de Quebec-Universite Laval

Brief Summary:
This study evaluates whether a gel containing sodium thiosulfate deposited via a trans-tympanic injection on the round window of the middle ear could reduce the ototoxicity caused by the drug Cisplatin among patients with head and neck cancer treated by chemoradiation. One ear selected randomly will be treated while the other will serve as control.

Condition or disease Intervention/treatment Phase
DDP Head and Neck Cancer Adverse Effect Drug: Trans-tympanic injection of a sodium thiosulfate gel Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial to Test the Efficacy of Trans-tympanic Injections of a Sodium Thiosulfate Gel to Prevent Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treated ear
Trans-tympanic injection of a sodium thiosulfate gel
Drug: Trans-tympanic injection of a sodium thiosulfate gel
A sodium thiosulfate hyaluronate gel will be prepared by mixing 0.55 ml of a 25% solution of sodium thiosulfate pentahydrate (Seacalphyx, DIN 02386666, Seaford Pharmaceuticals Inc.) and 0.55 ml of a hyaluronate gel (Healon 10 mg, Abbott Medical Optics Inc.). On the day before each Cisplatin treatment an otologist will deposit 0.1 ml of the gel exactly on the round window of the middle ear.
Other Name: Seacalphyx

No Intervention: Control ear
No intervention



Primary Outcome Measures :
  1. Hearing loss at high frequencies [ Time Frame: One month after Cisplatin treatment ]
    Hearing loss defined by the difference between the average permanent threshold shift (PTS) in dB (decibel) at four pure tone high frequencies (9, 10, 12.5 and 14 kHz) using the data from the audiograms done before and one month after Cisplatin therapy, for each patient and for each ear.


Secondary Outcome Measures :
  1. Cochlear damage [ Time Frame: One month after Cisplatin treatment ]
    Cochlear damage defined by the difference between the distortion product otoacoustic emissions (DPOAEs) recording before and one month after Cisplatin therapy, for each patient and for each ear.

  2. Hearing loss at lower frequencies [ Time Frame: One month and one year after Cisplatin treatment ]
    Hearing loss defined by the difference between the average permanent threshold shift (PTS) in dB (decibel) at four pure tone frequencies (0.5 to 8 kHz) using the data from the audiograms done before and one month and one year after Cisplatin therapy, for each patient and for each ear.

  3. Adverse effects of trans-tympanic injections [ Time Frame: One month after Cisplatin treatment ]
    Ototoxicity severity according to CTCAE after each trans-tympanic injection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed locally advanced (stage III or IV) squamous cell carcinoma of the mouth, oropharynx, hypopharynx, or larynx scheduled to be treated with concomitant chemoradiation including Cisplatin100 mg/m2 3 times
  • Normal otoscopic findings and symmetrical hearing

Exclusion Criteria:

  • Karnofsky below 70

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281006


Locations
Canada
CHU de Quebec
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
Principal Investigator: Francois Meyer, MD, DSc CHU de Quebec /université Laval

Responsible Party: François Meyer, Researcher, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02281006     History of Changes
Other Study ID Numbers: A13-09-985
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Sodium thiosulfate
Antineoplastic Agents
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents