NCT05946577Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 140 (estimated)
- First submitted
- 5 May 2023
- Start date
- 9 Mar 2023
- Primary completion date
- 9 Jul 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Head and neck cancer
- NCT number
- NCT05946577
What you commit to
- Study type: Observational
- Planned participants: 140
- From 9 Mar 2023 to the primary completion date, 9 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with weekly cisplatin
Other illness
- Patient fitted for hearing disorders
- Significant cognitive disorders that may compromise the performance of the various assessments
Other
- Tinnitus grade ≥ 2 according to the SOMA-LENT scale
- Patient's refusal to participate in research
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radiotherapy Oncology Service TENON Hospital Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.