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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

140 Participants
are grouped into 2 trial groups
Group A: Patients treated by chemoradiotherapy with high dose of cisplatin
Group B: Patients treated with exclusive radiotherapy or radiotherapy with non-ototoxic chemotherapy

Trial outcomes

Primary outcomes

1

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

Time frame
3 months after treatment

Secondary outcomes

1

Tinnitus incidence

According to Subjective, Objective, Management, Analytic- Late Effects Normal Tissue scales :SOMA-LENT scale (grade 1 to 4).

Time frame
at inclusion, at 3 weeks, at 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
2

Hearing loss incidence

audiogram with measures at 0,25, 0,5, 1, 2, 4, 6, 8, 10 and 12,5 kHz

Time frame
at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
3

Association between the onset of tinnitus and/or hearing loss and quality of life

Evaluation quality of life (Tinnitus Handicap Inventory)

Time frame
at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
4

Association between the onset of tinnitus and/or hearing loss and quality of life

Evaluation quality of life: EVA intensity and discomfort

Time frame
at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months

Other outcomes

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