Ringing in the Ears and Hearing Loss in Head and Neck Cancer Treatment
Studies ringing in the ears and hearing loss in adults with head and neck cancer.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- Association Between Tinnitus and Hearing Loss in Locally Advanced Head and Neck Cancer Treated by Radiotherapy Alone or With Chemotherapy: a Prospective and Multicenter Study
- Status
- Recruiting
- People taking part
- 140 people, planned
- Started
- 9 Mar 2023
- Expected to end
- 9 Mar 2029
- Type of study
- Observational, 2 groups
- Record updated
- 13 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with locally advanced head and neck cancer who have not yet had chemotherapy or radiotherapy and will get radiotherapy alone or with chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced or post-operative ear, nose and throat cancer with a high risk of coming back
- Earlier treatment
- No earlier chemotherapy or radiotherapy
Main reasons for not taking part
- Tinnitus grade 2 or higher on the SOMA-LENT scale
- Wearing a hearing aid for hearing problems
- Significant cognitive disorders that could affect the tests
- Treatment with weekly cisplatin
- Refusing to take part in the research
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Patients treated with weekly cisplatin
- Patient fitted for hearing disorders
- Significant cognitive disorders that may compromise the performance of the various assessments
- Tinnitus grade ≥ 2 according to the SOMA-LENT scale
- Patient's refusal to participate in research
Where in France
- Radiotherapy Oncology Service TENON HospitalParis, FranceContact: Florence HUGUET, MD, PhDTaking people
About the trial
What the trial wants to find out
The aim of the AURACCO study is to evaluate the association between the onset of tinnitus and hearing loss in patients with locally advanced head and neck cancer treated by concomitant chemoradiotherapy or exclusive radiotherapy
The 2 groups in the trial
- Patients treated by chemoradiotherapy with high dose of cisplatin
radiotherapy 60-70 Gy in 30-35 fractions with concomitant chemotherapy by cisplatin 100 mg/m2 every 3 weeks (week 1, 3 and 7)
- Patients treated with exclusive radiotherapy or radiotherapy with non-ototoxic chemotherapy
patient ineligible for chemotherapy with cisplatin: * exclusive radiotherapy: 60-70 Gy in 30-35 fractions * radiotherapy with a non-ototoxic chemotherapy (due to contraindication to cisplatin): 60-70 Gy in 30-35 fractions
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Association Between Tinnitus and Hearing Loss in Patients With Locally Advanced Head and Neck Cancer Treated by Concomitant Chemoradiotherapy or Exclusive Radiotherapy: a Prospective and Multicenter Study
- Plain-language title
- Ringing in the Ears and Hearing Loss in Head and Neck Cancer TreatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 August 2026