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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: 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

Study ID: NCT05946577

Interventions

Study Description

Brief 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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Radiotherapy Oncology Service TENON Hospital, Paris, , France

Contact Details

Name: Florence HUGUET, MD, PhD

Affiliation: Assistance Publique - Hôpitaux de Paris

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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