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 (AURACCO)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Head Cancer; Neck Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05946577

APHP230058

IDRCB 2022-A02685-38 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

140 participants in 2 patient groups

Patients treated by chemoradiotherapy with high dose of cisplatin

Description:

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

Description:

patient ineligible for chemotherapy with cisplatin: * exclusive radiotherapy: 60-70 Gy in 30-35 fractions * radiotherapy with a non-ototoxic chemotherapy (due to contraindication to cisplatin): 60-70 Gy in 30-35 fractions