Head CancerAURACCONCT05946577
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
An observational study of Head Cancer and Neck Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Cancer, Neck Cancer
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2023to 9 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rafik NEBBACHE, Resident contact
France1 site, 1 recruiting
- Recruiting
Radiotherapy Oncology Service TENON Hospital
Paris, 75020
Florence HUGUET, MD, PhD, 33 (0) 1 56 01 62 10, Florence.huguet@aphp.fr
Rafik NEBBACHE, Resident, Rafik.nebbache@aphp.fr
About this 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
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
Read the 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
- 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
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Salivary Gland Neoplasms, Ototoxicity, Tinnitus, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after treatment
Secondary outcomes (10)
Tinnitus incidence
According to Subjective, Objective, Management, Analytic- Late Effects Normal Tissue scales :SOMA-LENT scale (grade 1 to 4).
Measured: at inclusion, at 3 weeks, at 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
Hearing loss incidence
audiogram with measures at 0,25, 0,5, 1, 2, 4, 6, 8, 10 and 12,5 kHz
Measured: 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
Evaluation quality of life (Tinnitus Handicap Inventory)
Measured: 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
Evaluation quality of life: EVA intensity and discomfort
Measured: 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
Evaluation quality of life: EQ-5D-5L questionnaire
Measured: 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)
using SOMA-LENT criteria and audiogram
Measured: 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
mean dose and max dose
Measured: 3 months after treatment
Association between radiotherapy dose received on the cochlea and hearing loss
mean dose and max dose
Measured: 3 months after treatment
Association between cisplatin dose received and the onset of tinnitus and/or hearing loss
dose in mg/m2
Measured: 3 months after treatment
Quality of life after hearing aid fitting in patients requiring hearing aid during/after treatment
APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire
Measured: at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start9 Mar 2023
- Primary completion9 Jul 2027 (estimated)
- Study completion9 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence HUGUET, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946577
- Sponsor's protocol ID
- APHP230058
- Other IDs
- IDRCB 2022-A02685-38
- Acronym
- AURACCO
- Status last verified
- Aug 2026
- First submitted
- 5 May 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05946577
- Acronym / sponsor ID
- AURACCO / APHP230058
- Conditions
- Head Cancer, Neck Cancer
- Keywords
- Head and neck cancer, HNSCC, Undifferentiated nasopharyngeal cancer, UCNT, Salivary gland cancer, Radiotherapy, Chemoradiotherapy, Radiochemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 9 Jul 2027 (estimated)
- Study completion
- 9 Mar 2029 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
Tinnitus incidence
Time frame: 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
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
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
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
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
Association between radiotherapy dose received on the cochlea and the onset of tinnitus
Time frame: 3 months after treatment
Association between radiotherapy dose received on the cochlea and hearing loss
Time frame: 3 months after treatment
Association between cisplatin dose received and the onset of tinnitus and/or hearing loss
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafik NEBBACHE, Resident contact
Florence HUGUET, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Cancer and Neck Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence HUGUET, MD, PhD (0033 (0) 1 56 01 62 10, Florence.huguet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between the onset of tinnitus and hearing loss at 3 months after treatment (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.