Study Stopped
poor accrual
Efficacy of Trans-tympanic Injections of a Sodium Thiosulfate Gel to Prevent Cisplatin-induced Ototoxicity
STS001
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
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 3, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2017
CompletedJanuary 27, 2017
January 1, 2017
2.1 years
October 30, 2014
January 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hearing loss at high frequencies
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.
One month after Cisplatin treatment
Secondary Outcomes (3)
Cochlear damage
One month after Cisplatin treatment
Hearing loss at lower frequencies
One month and one year after Cisplatin treatment
Adverse effects of trans-tympanic injections
One month after Cisplatin treatment
Study Arms (2)
Treated ear
EXPERIMENTALTrans-tympanic injection of a sodium thiosulfate gel
Control ear
NO INTERVENTIONNo intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Karnofsky below 70
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Quebec
Québec, Quebec, G1R 2J6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francois Meyer, MD, DSc
CHU de Quebec (Université Laval)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 3, 2014
Study Start
January 1, 2015
Primary Completion
January 20, 2017
Study Completion
January 20, 2017
Last Updated
January 27, 2017
Record last verified: 2017-01