Transtympanic sodium thiosulfate to prevent cisplatin-related hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized phase III trial that uses each patient as their own control by treating one ear with transtympanic sodium thiosulfate (STS) gel and leaving the other ear untreated. About 100 adults with head and neck cancers who will receive a cumulative cisplatin dose ≥200 mg/m2 will be randomized to receive the STS injection into one ear within three hours before each cisplatin infusion (3–7 injections per patient). Hearing tests and questionnaires are done at baseline and 2–4 months after the last cisplatin dose, and the audiometrist conducting tests is blinded to which ear was treated. Patients will have routine follow-up for survival data for a median of about two years after treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological or cytological proof of solid head and neck malignancies with an indication for treatment with cisplatin in a cumulative dose of ≥ 200mg/m2 given in a weekly schedule of 7 times 40 mg/m2 or a 3-weekly schedule of 3 times 100 mg/m2
* Treatment with high-dose cisplatin (cumulative dose ≥ 200mg/m2) of maximum 7 cycles
* Able and willing to give written informed consent;
* WHO performance status of 0, 1 or 2;
* Age older than 18 years.

Exclusion Criteria:

* Asymmetric hearing capacity (SNHL) prior to treatment, defined as a difference between both ears in hearing capacity of ≥ 10 dB averaged over 3 adjacent frequencies in the range of 0.5 to 12.5 kHz (i.e. 0.5, 1, 2, 4, 8, 10 and 12.5 kHz).
* Baseline hearing: more than 40 dB SNHL at PTA 1-2-4 kHz (in one or both ears)
* A planned radiation dose of \> 30 Gy to the cochlea (8);
* Known hypersensitivity to STS-containing HYA gel formulation;
* Any condition that would, according to the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures;
* Otologic pathology that hampers the transtympanically applied STS gel to diffuse through the round window, e.g. otosclerosis, a narrow ear canal, otitis media with effusion.

Where it's running

• Antoni van Leeuwenhoek
  Amsterdam, North Holland, Netherlands Recruiting
• Leiden University Medical Center
  Leiden, South Holland, Netherlands Recruiting
• Erasmus Universitair Medisch Centrum Rotterdam
  Rotterdam, South Holland, Netherlands Not yet recruiting
• University Medical Center Utrecht
  Utrecht, Utrecht, Netherlands Not yet recruiting
• Stichting Radboud University Medical Center
  Nijmegen, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Lotje Zuur, Prof. Dr. — Avl
• Study coordinator: Daniël Griffioen, MD
• Email: da.griffioen@nki.nl
• Phone: +31205129111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.