Tinnitus and Hearing Loss in Head and Neck Cancer Treated with Radiotherapy or Chemoradiotherapy

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 prospective, multicenter observational study follows adults with locally advanced or high-risk post-operative head and neck cancer treated with standard radiotherapy with or without cisplatin. It collects patient and treatment data, including cochlear radiation exposure, to explore the relationship between tinnitus onset during treatment and subsequent hearing loss. Data are gathered from four Paris centers to characterize timing, severity, and potential predictors. The study aims to clarify whether tinnitus can act as an early signal of treatment-related hearing damage in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient with locally advanced or post-operative ENT cancer with high risk of recurrence
* Patient ≥ 18 years
* Absence of prior chemotherapy or radiotherapy
* Patient eligible for chemotherapy with cisplatin according to the standard regimen: radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks associated with chemotherapy with cisplatin 100 mg/m2 every 3 weeks (i.e. at week 1, 4 and 7)
* Patient ineligible for cisplatin chemotherapy receiving:

  * Either exclusive radiotherapy (age \> 70 years, contraindication: renal failure, patient wearing a device): radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks.
  * either chemoradiotherapy with a chemotherapy protocol different from the standard scheme (due to a contraindication to cisplatin): radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks associated with non-standard chemotherapy ototoxic (cetuximab or carboplatin-5FU)

Exclusion Criteria:

* Tinnitus grade ≥ 2 according to the SOMA-LENT scale
* Patient fitted for hearing disorders
* Significant cognitive disorders that may compromise the performance of the various assessments
* Patients treated with weekly cisplatin
* Patient's refusal to participate in research

Where it's running

• Radiotherapy Oncology Service TENON Hospital
  Paris, France Recruiting

Study contacts

• Principal investigator: Florence HUGUET, MD, PhD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Florence HUGUET, MD, PhD
• Email: Florence.huguet@aphp.fr
• Phone: 0033 (0) 1 56 01 62 10

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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.