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

Neck Cancer Clinical Trial

— AURACCO  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05946577
• Other study ID #: APHP230058
• Secondary ID: IDRCB 2022-A0268
• Status: Not yet recruiting
• Start date: July 2023
• Est. completion date: September 2026

Study information

• Verified date: July 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Florence HUGUET, MD, PhD
• Phone: 0033 (0) 1 56 01 62 10
• Email: Florence.huguet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: September 2026
• Est. primary completion date: June 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Head and Neck Neoplasms
• Head Cancer
• Hearing Loss
• Neck Cancer
• Tinnitus

Locations

Country	Name	City	State
France	Radiotherapy Oncology Service TENON Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months after treatment
Secondary	Tinnitus incidence	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
Secondary	Hearing loss incidence	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
Secondary	Association between the onset of tinnitus and/or hearing loss and quality of life	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
Secondary	Association between the onset of tinnitus and/or hearing loss and quality of life	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
Secondary	Association between the onset of tinnitus and/or hearing loss and quality of life	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
Secondary	Evolution of hearing disorders (tinnitus and/or hearing loss)	using SOMA-LENT criteria and audiogram	at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months
Secondary	Association between radiotherapy dose received on the cochlea and the onset of tinnitus	mean dose and max dose	3 months after treatment
Secondary	Association between radiotherapy dose received on the cochlea and hearing loss	mean dose and max dose	3 months after treatment
Secondary	Association between cisplatin dose received and the onset of tinnitus and/or hearing loss	dose in mg/m2	3 months after treatment
Secondary	Quality of life after hearing aid fitting in patients requiring hearing aid during/after treatment	APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire	at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months