AURACCOAssociation 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
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveCarcinome épidermoïde de la tête et du cou+26
+ Ototoxicité
+ Carcinome
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 1 juillet 2023
Date à laquelle le premier participant a commencé l'étude.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
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.140 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Radiotherapy Oncology Service TENON Hospital
Paris, FranceOuvrir Radiotherapy Oncology Service TENON Hospital dans Google Maps