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)

August 11, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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:

  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between the onset of tinnitus and hearing loss at 3 months after treatment
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus incidence
Time Frame: 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).
at inclusion, at 3 weeks, at 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
Hearing loss incidence
Time Frame: 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
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
Time Frame: 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)
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
Time Frame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
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
Time Frame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
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)
Time Frame: at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
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
Time Frame: 3 months after treatment
mean dose and max dose
3 months after treatment
Association between radiotherapy dose received on the cochlea and hearing loss
Time Frame: 3 months after treatment
mean dose and max dose
3 months after treatment
Association between cisplatin dose received and the onset of tinnitus and/or hearing loss
Time Frame: 3 months after treatment
dose in mg/m2
3 months after treatment
Quality of life after hearing aid fitting in patients requiring hearing aid during/after treatment
Time Frame: at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire
at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Florence HUGUET, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Estimated)

July 9, 2027

Study Completion (Estimated)

March 9, 2029

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230058
  • IDRCB 2022-A02685-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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