NCT05946577

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Detailed description

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

Conditions

• Head Cancer
• Neck Cancer

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-06-01
• Completion: 2026-09-01
• First posted: 2023-07-14
• Last updated: 2023-07-14

Locations

1 site across 1 country: France