Clinical trial 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
Official title: Association Between Tinnitus and Hearing Loss in Patients With Locally Advanced Head and Neck Cancer Treated by Concomitant Chemoradiotherapy or Exclusive Radiotherapy: a Prospective and Multicenter Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Head Cancer
Neck Cancer
Keywords: Head and neck cancer
HNSCC
Undifferentiated nasopharyngeal cancer
UCNT
Salivary gland cancer
Radiotherapy
Chemoradiotherapy
Radiochemotherapy
Chemotherapy
Cisplatin
Ototoxicity
Tinnitus
Hearing loss
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

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

Primary outcomes:
measure: Association between the onset of tinnitus and hearing loss at 3 months after treatment
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Tinnitus incidence
timeFrame: at inclusion, at 3 weeks, at 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
measure: Hearing loss incidence
timeFrame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
measure: Association between the onset of tinnitus and/or hearing loss and quality of life
timeFrame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
measure: Association between the onset of tinnitus and/or hearing loss and quality of life
timeFrame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
measure: Association between the onset of tinnitus and/or hearing loss and quality of life
timeFrame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
measure: Evolution of hearing disorders (tinnitus and/or hearing loss)
timeFrame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
measure: Association between radiotherapy dose received on the cochlea and the onset of tinnitus
timeFrame: 3 months after treatment
measure: Association between radiotherapy dose received on the cochlea and hearing loss
timeFrame: 3 months after treatment
measure: Association between cisplatin dose received and the onset of tinnitus and/or hearing loss
timeFrame: 3 months after treatment
measure: Quality of life after hearing aid fitting in patients requiring hearing aid during/after treatment
timeFrame: at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Radiotherapy Oncology Service TENON Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Florence HUGUET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: