Clinical trial · Observational
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
NCT05946577CI-TRIAL-00121988AURACCOrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head Cancer | — | UNRESOLVED | — |
| Neck Cancer | Malignant Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients treated by chemoradiotherapy with high dose of cisplatin
- description
- radiotherapy 60-70 Gy in 30-35 fractions with concomitant chemotherapy by cisplatin 100 mg/m2 every 3 weeks (week 1, 3 and 7)
- label
- Patients treated with exclusive radiotherapy or radiotherapy with non-ototoxic chemotherapy
- description
- 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
Primary outcomes (1)
- measure
- Association between the onset of tinnitus and hearing loss at 3 months after treatment
- timeFrame
- 3 months after treatment
- description
- Evaluation of the tinnitus on each ear. Hearing loss is defined as a loss of more than 20 dB compared to the measurement made at inclusion
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.