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
| NCT ID | NCT05946577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Head Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-03-09 |
| Primary Completion | 2027-07-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2023-03-09 with a primary completion date of 2027-07-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Florence HUGUET, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05946577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05946577 currently recruiting?
Yes, NCT05946577 is actively recruiting participants. Contact the research team at Florence.huguet@aphp.fr for enrollment information.
Where is the NCT05946577 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05946577 clinical trial?
NCT05946577 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Florence HUGUET, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 140 participants.
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