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
Radiotherapy with or without concomitant chemotherapy is the standard of care for patients diagnosed with locally advanced head and neck cancer. This treatment is associated with many side effects, especially tinnitus and hearing loss affecting patients' quality of life. Theses toxicities are due to chemotherapy and radiotherapy, with a synergic effect. The effects of chemoradiotherapy on hearing loss are already well documented but very limited data are available on the onset of tinnitus. Currently, no study established a correlation between tinnitus and hearing loss after treatment by chemoradiotherapy or exclusive radiotherapy. The main question we aim to answer is whether the development of tinnitus during treatment can be a precursor to hearing loss? Clinical data will be collected prospectively in 4 centers in Paris (Hôpital Tenon, Hôpital La Pitié-Salpêtrrière, Hôpital Saint-Louis and Hôpital Européen Georges Pompidou) to collect : * Patient data : * Birth date (age at diagnosis) * Tobacco use (active : yes/no, quantity in pack-year) * Alcohol use (active : yes/no, quantity in g/day) * Sex * Disease data : * Primitive site (oral cavity, nasopharynx, oropharynx, larynx, sinus, salivary gland, carcinoma with unknown primitive) * Histological type * HPV status * TNM stage * Data at diagnosis * Treatment data : * Post-operative situation (yes/no) * Radiotherapy dose received and number of fraction * Mean and max doses received in Gy on the right and left cochleas * Other otototoxic treatment taken during radiotherapy * Evaluation data : * Tinnitus evaluation (using SOMA-LENT criteria) * Audiogram with measures at 0,25, 0,5, 1, 2, 4, 6, 8, 10 and 12,5 kHz * Check for hearing "microloss" * If tinnitus present : acouphénométrie * If hearing aid fitting indication : APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire
Study Type
OBSERVATIONAL
Enrollment
140
Radiotherapy Oncology Service TENON Hospital
Paris, France
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
Time frame: 3 months after treatment
Tinnitus incidence
According to Subjective, Objective, Management, Analytic- Late Effects Normal Tissue scales :SOMA-LENT scale (grade 1 to 4).
Time frame: at inclusion, at 3 weeks, at 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
Hearing loss incidence
audiogram with measures at 0,25, 0,5, 1, 2, 4, 6, 8, 10 and 12,5 kHz
Time frame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
Association between the onset of tinnitus and/or hearing loss and quality of life
Evaluation quality of life (Tinnitus Handicap Inventory)
Time frame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
Association between the onset of tinnitus and/or hearing loss and quality of life
Evaluation quality of life: EVA intensity and discomfort
Time frame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
Association between the onset of tinnitus and/or hearing loss and quality of life
Evaluation quality of life: EQ-5D-5L questionnaire
Time frame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
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Evolution of hearing disorders (tinnitus and/or hearing loss)
using SOMA-LENT criteria and audiogram
Time frame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
Association between radiotherapy dose received on the cochlea and the onset of tinnitus
mean dose and max dose
Time frame: 3 months after treatment
Association between radiotherapy dose received on the cochlea and hearing loss
mean dose and max dose
Time frame: 3 months after treatment
Association between cisplatin dose received and the onset of tinnitus and/or hearing loss
dose in mg/m2
Time frame: 3 months after treatment
Quality of life after hearing aid fitting in patients requiring hearing aid during/after treatment
APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire
Time frame: at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months