Association Between Tinnitus and Hearing Loss in Locally Advanced Head and Neck Cancer Treated by… (NCT05946577) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
France140 participantsStarted 2023-07
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Association between the onset of tinnitus and hearing loss at 3 months after treatment