Head Cancer, Neck Cancer
Conditions
Keywords
Head and neck cancer, HNSCC, Undifferentiated nasopharyngeal cancer, UCNT, Salivary gland cancer, Radiotherapy, Chemoradiotherapy, Radiochemotherapy, Chemotherapy, Cisplatin, Ototoxicity, Tinnitus, Hearing loss
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
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between the onset of tinnitus and hearing loss at 3 months after treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus incidence | at inclusion, at 3 weeks, at 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months | According to Subjective, Objective, Management, Analytic- Late Effects Normal Tissue scales :SOMA-LENT scale (grade 1 to 4). |
| Hearing loss incidence | at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months | audiogram with measures at 0,25, 0,5, 1, 2, 4, 6, 8, 10 and 12,5 kHz |
| Association between the onset of tinnitus and/or hearing loss and quality of life | at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months | Evaluation quality of life (Tinnitus Handicap Inventory) |
| Evolution of hearing disorders (tinnitus and/or hearing loss) | at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months | using SOMA-LENT criteria and audiogram |
| Association between radiotherapy dose received on the cochlea and the onset of tinnitus | 3 months after treatment | mean dose and max dose |
| Association between radiotherapy dose received on the cochlea and hearing loss | 3 months after treatment | mean dose and max dose |
| Association between cisplatin dose received and the onset of tinnitus and/or hearing loss | 3 months after treatment | dose in mg/m2 |
| Quality of life after hearing aid fitting in patients requiring hearing aid during/after treatment | at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months | APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire |
Countries
France
Contacts
CONTACTFlorence HUGUET, MD, PhD
CONTACTRafik NEBBACHE, Resident
PRINCIPAL_INVESTIGATORFlorence HUGUET, MD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed