About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients followed in Hôpital Tenon, Hôpital Pitié-Salpétrière, Hôpital Saint-Louis or Hôpital Européen Georges Pompidou for a histological diagnosis of locally advanced head and neck cancer with an indication for concomitant chemoradiotherapy or exclusive radiotherapy.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Association between the onset of tinnitus and hearing loss at 3 months after treatment
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
Tinnitus incidence
According to Subjective, Objective, Management, Analytic- Late Effects Normal Tissue scales :SOMA-LENT scale (grade 1 to 4).
Hearing loss incidence
audiogram with measures at 0,25, 0,5, 1, 2, 4, 6, 8, 10 and 12,5 kHz
Association between the onset of tinnitus and/or hearing loss and quality of life
Evaluation quality of life (Tinnitus Handicap Inventory)
Association between the onset of tinnitus and/or hearing loss and quality of life
Evaluation quality of life: EVA intensity and discomfort
Sponsors and contacts
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