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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2022-A02685-38 | Other Identifier | ANSM |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated by chemoradiotherapy with high dose of cisplatin | radiotherapy 60-70 Gy in 30-35 fractions with concomitant chemotherapy by cisplatin 100 mg/m2 every 3 weeks (week 1, 3 and 7) | ||
| Patients treated with exclusive radiotherapy or radiotherapy with non-ototoxic chemotherapy | patient ineligible for chemotherapy with cisplatin:
|
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| Measure | Description | Time Frame |
|---|---|---|
| Association between the onset of tinnitus and hearing loss at 3 months after treatment | Evaluation of the tinnitus on each ear. Hearing loss is defined as a loss of more than 20 dB compared to the measurement made at inclusion | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus incidence | According to Subjective, Objective, Management, Analytic- Late Effects Normal Tissue scales :SOMA-LENT scale (grade 1 to 4). | at inclusion, at 3 weeks, at 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months |
| Hearing loss incidence |
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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:
Exclusion Criteria:
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Patients followed in Hôpital Tenon, Hôpital Pitié-Salpétrière, Hôpital Saint-Louis or Hôpital Européen Georges Pompidou for a histological diagnosis of locally advanced head and neck cancer with an indication for concomitant chemoradiotherapy or exclusive radiotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence HUGUET, MD, PhD | Contact | 0033 (0) 1 56 01 62 10 | Florence.huguet@aphp.fr | |
| Rafik NEBBACHE, Resident | Contact | Rafik.nebbache@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florence HUGUET, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiotherapy Oncology Service TENON Hospital | Paris | 75020 | France |
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audiogram with measures at 0,25, 0,5, 1, 2, 4, 6, 8, 10 and 12,5 kHz |
| at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months |
| Association between the onset of tinnitus and/or hearing loss and quality of life | Evaluation quality of life (Tinnitus Handicap Inventory) | at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months |
| Association between the onset of tinnitus and/or hearing loss and quality of life | Evaluation quality of life: EVA intensity and discomfort | at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months |
| Association between the onset of tinnitus and/or hearing loss and quality of life | Evaluation quality of life: EQ-5D-5L questionnaire | at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months |
| Evolution of hearing disorders (tinnitus and/or hearing loss) | using SOMA-LENT criteria and audiogram | at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months |
| Association between radiotherapy dose received on the cochlea and the onset of tinnitus | mean dose and max dose | 3 months after treatment |
| Association between radiotherapy dose received on the cochlea and hearing loss | mean dose and max dose | 3 months after treatment |
| Association between cisplatin dose received and the onset of tinnitus and/or hearing loss | dose in mg/m2 | 3 months after treatment |
| Quality of life after hearing aid fitting in patients requiring hearing aid during/after treatment | APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire | at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D012468 | Salivary Gland Neoplasms |
| D000081015 | Ototoxicity |
| D014012 | Tinnitus |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D006311 | Hearing Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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